Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT04494256
Status:
TERMINATED
Last Update Posted:
2025-10-09
First Post:
2020-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Assess the Safety, Tolerability, and Effect on Disease Progression of BIIB105 in Participants With Amyotrophic Lateral Sclerosis (ALS) and Participants With the ALS Ataxin-2 (ATXN2) Genetic Mutation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@biogen.com', 'phone': '866-633-4636', 'title': 'US Biogen Clinical Trial Center', 'organization': 'Biogen'}, 'certainAgreement': {'otherDetails': "Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': "Study terminated because of sponsor's decision."}}, 'adverseEventsModule': {'timeFrame': 'From first dose of the study drug up to end of follow up period in Part 1 (up to Day 260) and Part 2 (up to Day 1184)', 'description': 'The Part 1 safety analysis population included all randomized participants who received at least 1 dose of study treatment in Part 1. The Part 2 safety analysis population included all participants who received at least 1 dose of study treatment in Part 2.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: Pooled Placebo 1+2', 'description': 'Participants with ALS and polyQ-ALS from Cohorts A, B, C1 and C2 received 3 loading doses of BIIB105-matched placebo, administered every 2 weeks (on Days 1, 15 and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks. Participants with ALS and polyQ-ALS from Cohorts D1 and D2 received 3 loading doses of BIIB105- matched placebo administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 27, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Part 1: Cohort A: BIIB105 5 mg', 'description': 'Participants with ALS received 3 loading doses of BIIB105 5mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part 1: Cohort B: BIIB105 20 mg', 'description': 'Participants with ALS received 3 loading doses of BIIB105 20 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part 1: Cohorts C1+C2: BIIB105 60 mg', 'description': 'Participants with ALS (Cohort C1) and polyQ-ALS (Cohort C2) received 3 loading doses of BIIB105 60 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Part 1: Cohorts D1 + D2: BIIB105 120 mg', 'description': 'Participants with ALS (Cohort D1) and polyQ-ALS (Cohort D2) received BIIB105 120 mg, IT, as 3 loading doses administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 47, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG005', 'title': 'Part 2: BIIB105 60 mg', 'description': 'Participants from cohorts A-C2, who received 5, 20 and 60 mg doses of BIIB105 and placebo in Part 1 and completed Week 25 (Day 175) visit in Part 1 received BIIB105 60 mg in Part 2.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 19, 'seriousNumAtRisk': 19, 'deathsNumAffected': 4, 'seriousNumAffected': 7}, {'id': 'EG006', 'title': 'Part 2: BIIB105 120 mg', 'description': 'Participants from Cohorts D1 and D2 who received 120 mg dose of BIIB105 and placebo in Part 1 and completed Week 25 (Day 176) visit in Part 1 received BIIB105 120 mg in Part 2.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 45, 'seriousNumAtRisk': 51, 'deathsNumAffected': 2, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypoacusis', 'stats': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Oral dysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 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0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Amyotrophic lateral sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cerebral venous sinus thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Toxic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Chronic respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 48, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Pooled Placebo 1+2', 'description': 'Participants with ALS and polyQ-ALS from Cohorts A, B, C1 and C2 received 3 loading doses of BIIB105-matched placebo, administered every 2 weeks (on Days 1, 15 and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks. Participants with ALS and polyQ-ALS from Cohorts D1 and D2 received 3 loading doses of BIIB105- matched placebo administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.'}, {'id': 'OG001', 'title': 'Part 1: Cohort A: BIIB105 5 mg', 'description': 'Participants with ALS received 3 loading doses of BIIB105 5 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'OG002', 'title': 'Part 1: Cohort B: BIIB105 20 mg', 'description': 'Participants with ALS received 3 loading doses of BIIB105 20 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'OG003', 'title': 'Part 1: Cohorts C1+C2: BIIB105 60 mg', 'description': 'Participants with ALS (Cohort C1) and polyQ-ALS (Cohort C2) received 3 loading doses of BIIB105 60 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'OG004', 'title': 'Part 1: Cohorts D1 + D2: BIIB105 120 mg', 'description': 'Participants with ALS (Cohort D1) and polyQ-ALS (Cohort D2) received 3 loading doses of BIIB105 120 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}]}]}, {'title': 'TESAEs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of the study drug in Part 1 up to end of follow up period in Part 1 (up to Day 260)', 'description': 'An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event. A TEAE/TESAE was defined as any AE/SAE with an onset date that is on or after the first dose of study drug or any pre-existing condition that has worsened in severity after the first dose of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Part 1 safety analysis population included all randomized participants who received at least 1 dose of study treatment in Part 1.'}, {'type': 'PRIMARY', 'title': 'Part 2: Number of Participants With TEAEs and TESAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: BIIB105 60 mg', 'description': 'Participants from cohorts A-C2, who received 5, 20 and 60 mg BIIB105 and placebo in Part 1 and completed Week 25 (Day 175) Visit in Part 1 received BIIB105 60 mg in Part 2.'}, {'id': 'OG001', 'title': 'Part 2: BIIB105 120 mg', 'description': 'Participants from Cohorts D1 and D2 randomised to BIIB105 120 mg and placebo in Part 1 and completed Week 25 (Day 176) Visit in Part 1 received BIIB105 at 120 mg in Part 2.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'TESAEs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of the study in Part 2 up to end of follow up period in Part 2 (up to Day 1184)', 'description': 'An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event. A TEAE/TESAE was defined as any AE/SAE with an onset date that is on or after the first dose of study drug or any pre-existing condition that has worsened in severity after the first dose of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Part 2 safety analysis population included all randomized participants who received at least 1 dose of study treatment in Part 2.'}, {'type': 'SECONDARY', 'title': 'Part 1: Serum Concentrations of BIIB105', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Cohort A: BIIB105 5 mg', 'description': 'Participants with ALS received 3 loading doses of BIIB105 5 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'OG001', 'title': 'Part 1: Cohort B: BIIB105 20 mg', 'description': 'Participants with ALS received 3 loading doses of BIIB105 20 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'OG002', 'title': 'Part 1: Cohorts C1+C2: BIIB105 60 mg', 'description': 'Participants with ALS (Cohort C1) and polyQ-ALS (Cohort C2) received 3 loading doses of BIIB105 60 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'OG003', 'title': 'Part 1: Cohorts D1 + D2: BIIB105 120 mg', 'description': 'Participants with ALS (Cohort D1) and polyQ-ALS (Cohort D2) received 3 loading doses of BIIB105 120 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.'}], 'classes': [{'title': 'Day 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG003'}]}]}, {'title': 'Day 1: 1 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.21', 'spread': '500.18', 'groupId': 'OG000'}, {'value': '57.70', 'spread': '285.30', 'groupId': 'OG001'}, {'value': '34.98', 'spread': '465.78', 'groupId': 'OG002'}, {'value': '187.14', 'spread': '351.05', 'groupId': 'OG003'}]}]}, {'title': 'Day 1: 2 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '32.20', 'spread': '177.01', 'groupId': 'OG000'}, {'value': '135.71', 'spread': '109.27', 'groupId': 'OG001'}, {'value': '250.28', 'spread': '101.57', 'groupId': 'OG002'}, {'value': '620.38', 'spread': '132.37', 'groupId': 'OG003'}]}]}, {'title': 'Day 1: 4 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '41.38', 'spread': '125.95', 'groupId': 'OG000'}, {'value': '211.34', 'spread': '68.29', 'groupId': 'OG001'}, {'value': '488.11', 'spread': '51.22', 'groupId': 'OG002'}, {'value': '798.21', 'spread': '86.03', 'groupId': 'OG003'}]}]}, {'title': 'Day 1: 6 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '39.27', 'spread': '102.97', 'groupId': 'OG000'}, {'value': '165.05', 'spread': '60.63', 'groupId': 'OG001'}, {'value': '528.45', 'spread': '61.49', 'groupId': 'OG002'}, {'value': '774.73', 'spread': '60.51', 'groupId': 'OG003'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.76', 'spread': '65.90', 'groupId': 'OG000'}, {'value': '29.07', 'spread': '76.82', 'groupId': 'OG001'}, {'value': '118.70', 'spread': '103.89', 'groupId': 'OG002'}, {'value': '260.03', 'spread': '67.59', 'groupId': 'OG003'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.46', 'spread': '18.74', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '36.02', 'groupId': 'OG001'}, {'value': '1.38', 'spread': '74.15', 'groupId': 'OG002'}, {'value': '2.97', 'spread': '43.60', 'groupId': 'OG003'}]}]}, {'title': 'Day 15: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '20.12', 'groupId': 'OG001'}, {'value': '0.78', 'spread': '52.94', 'groupId': 'OG002'}, {'value': '1.90', 'spread': '43.15', 'groupId': 'OG003'}]}]}, {'title': 'Day 15: 1 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.85', 'spread': '172.70', 'groupId': 'OG000'}, {'value': '22.24', 'spread': '226.26', 'groupId': 'OG001'}, {'value': '56.01', 'spread': '489.04', 'groupId': 'OG002'}, {'value': '257.73', 'spread': '290.21', 'groupId': 'OG003'}]}]}, {'title': 'Day 15: 2 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.89', 'spread': '111.49', 'groupId': 'OG000'}, {'value': '94.51', 'spread': '140.45', 'groupId': 'OG001'}, {'value': '246.73', 'spread': '142.61', 'groupId': 'OG002'}, {'value': '972.44', 'spread': '110.25', 'groupId': 'OG003'}]}]}, {'title': 'Day 15: 4 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '30.07', 'spread': '74.48', 'groupId': 'OG000'}, {'value': '139.75', 'spread': '137.49', 'groupId': 'OG001'}, {'value': '363.86', 'spread': '77.37', 'groupId': 'OG002'}, {'value': '996.20', 'spread': '83.48', 'groupId': 'OG003'}]}]}, {'title': 'Day 15: 6 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '27.28', 'spread': '106.96', 'groupId': 'OG000'}, {'value': '139.00', 'spread': '98.33', 'groupId': 'OG001'}, {'value': '411.61', 'spread': '49.33', 'groupId': 'OG002'}, {'value': '897.25', 'spread': '78.56', 'groupId': 'OG003'}]}]}, {'title': 'Day 29: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.45', 'spread': '24.48', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '28.47', 'groupId': 'OG001'}, {'value': '1.23', 'spread': '64.84', 'groupId': 'OG002'}, {'value': '2.59', 'spread': '59.99', 'groupId': 'OG003'}]}]}, {'title': 'Day 29: 1 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.80', 'spread': '117.90', 'groupId': 'OG000'}, {'value': '16.45', 'spread': '557.48', 'groupId': 'OG001'}, {'value': '114.69', 'spread': '226.87', 'groupId': 'OG002'}, {'value': '248.00', 'spread': '152.63', 'groupId': 'OG003'}]}]}, {'title': 'Day 29: 2 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.53', 'spread': '121.68', 'groupId': 'OG000'}, {'value': '51.58', 'spread': '602.03', 'groupId': 'OG001'}, {'value': '420.39', 'spread': '116.92', 'groupId': 'OG002'}, {'value': '773.11', 'spread': '95.92', 'groupId': 'OG003'}]}]}, {'title': 'Day 29: 4 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '31.29', 'spread': '120.91', 'groupId': 'OG000'}, {'value': '102.80', 'spread': '200.28', 'groupId': 'OG001'}, {'value': '566.43', 'spread': '71.83', 'groupId': 'OG002'}, {'value': '953.50', 'spread': '80.75', 'groupId': 'OG003'}]}]}, {'title': 'Day 29: 6 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '33.28', 'spread': '127.43', 'groupId': 'OG000'}, {'value': '151.47', 'spread': '87.99', 'groupId': 'OG001'}, {'value': '555.65', 'spread': '52.83', 'groupId': 'OG002'}, {'value': '942.06', 'spread': '69.00', 'groupId': 'OG003'}]}]}, {'title': 'Day 57: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '21.53', 'groupId': 'OG001'}, {'value': '0.79', 'spread': '80.26', 'groupId': 'OG002'}, {'value': '1.83', 'spread': '69.80', 'groupId': 'OG003'}]}]}, {'title': 'Day 57: 1 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.45', 'spread': '275.61', 'groupId': 'OG000'}, {'value': '7.98', 'spread': '159.54', 'groupId': 'OG001'}, {'value': '44.33', 'spread': '615.14', 'groupId': 'OG002'}, {'value': '227.06', 'spread': '214.59', 'groupId': 'OG003'}]}]}, {'title': 'Day 57: 2 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22.05', 'spread': '153.51', 'groupId': 'OG000'}, {'value': '26.59', 'spread': '107.62', 'groupId': 'OG001'}, {'value': '274.02', 'spread': '128.39', 'groupId': 'OG002'}, {'value': '713.36', 'spread': '122.48', 'groupId': 'OG003'}]}]}, {'title': 'Day 57: 4 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '27.72', 'spread': '123.67', 'groupId': 'OG000'}, {'value': '74.60', 'spread': '85.53', 'groupId': 'OG001'}, {'value': '471.12', 'spread': '95.76', 'groupId': 'OG002'}, {'value': '887.82', 'spread': '105.32', 'groupId': 'OG003'}]}]}, {'title': 'Day 57: 6 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '27.33', 'spread': '105.30', 'groupId': 'OG000'}, {'value': '89.38', 'spread': '74.82', 'groupId': 'OG001'}, {'value': '416.91', 'spread': '94.12', 'groupId': 'OG002'}, {'value': '889.54', 'spread': '89.20', 'groupId': 'OG003'}]}]}, {'title': 'Day 85: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '33.26', 'groupId': 'OG001'}, {'value': '0.74', 'spread': '64.453', 'groupId': 'OG002'}, {'value': '1.91', 'spread': '113.18', 'groupId': 'OG003'}]}]}, {'title': 'Day 85: 1 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.02', 'spread': '111.81', 'groupId': 'OG000'}, {'value': '18.91', 'spread': '240.40', 'groupId': 'OG001'}, {'value': '77.63', 'spread': '142.75', 'groupId': 'OG002'}, {'value': '231.31', 'spread': '236.91', 'groupId': 'OG003'}]}]}, {'title': 'Day 85: 2 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.60', 'spread': '95.33', 'groupId': 'OG000'}, {'value': '69.04', 'spread': '265.82', 'groupId': 'OG001'}, {'value': '248.33', 'spread': '84.14', 'groupId': 'OG002'}, {'value': '651.00', 'spread': '127.92', 'groupId': 'OG003'}]}]}, {'title': 'Day 85: 4 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '27.69', 'spread': '111.28', 'groupId': 'OG000'}, {'value': '140.04', 'spread': '91.00', 'groupId': 'OG001'}, {'value': '416.74', 'spread': '80.90', 'groupId': 'OG002'}, {'value': '799.70', 'spread': '89.26', 'groupId': 'OG003'}]}]}, {'title': 'Day 85: 6 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '29.83', 'spread': '119.17', 'groupId': 'OG000'}, {'value': '140.74', 'spread': '50.95', 'groupId': 'OG001'}, {'value': '453.58', 'spread': '74.39', 'groupId': 'OG002'}, {'value': '837.50', 'spread': '73.65', 'groupId': 'OG003'}]}]}, {'title': 'Day 92', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.43', 'spread': '23.54', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '47.98', 'groupId': 'OG001'}, {'value': '2.05', 'spread': '92.02', 'groupId': 'OG002'}, {'value': '4.47', 'spread': '64.10', 'groupId': 'OG003'}]}]}, {'title': 'Day 113: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.95', 'spread': '59.79', 'groupId': 'OG003'}]}]}, {'title': 'Day 113: 1 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '193.04', 'spread': '198.68', 'groupId': 'OG003'}]}]}, {'title': 'Day 113: 2 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '632.28', 'spread': '91.07', 'groupId': 'OG003'}]}]}, {'title': 'Day 113: 4 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '802.46', 'spread': '91.76', 'groupId': 'OG003'}]}]}, {'title': 'Day 113: 6 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '858.58', 'spread': '86.76', 'groupId': 'OG003'}]}]}, {'title': 'Day 141: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.07', 'spread': '80.82', 'groupId': 'OG003'}]}]}, {'title': 'Day 141: 1 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '457.25', 'spread': '162.57', 'groupId': 'OG003'}]}]}, {'title': 'Day 141: 2 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '949.31', 'spread': '120.40', 'groupId': 'OG003'}]}]}, {'title': 'Day 141: 4 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1044.80', 'spread': '101.09', 'groupId': 'OG003'}]}]}, {'title': 'Day 141: 6 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '996.44', 'spread': '85.54', 'groupId': 'OG003'}]}]}, {'title': 'Day 169: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.95', 'spread': '153.02', 'groupId': 'OG003'}]}]}, {'title': 'Day 169: 1 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '288.75', 'spread': '217.19', 'groupId': 'OG003'}]}]}, {'title': 'Day 169: 2 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '702.24', 'spread': '107.10', 'groupId': 'OG003'}]}]}, {'title': 'Day 169: 4 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '816.90', 'spread': '86.61', 'groupId': 'OG003'}]}]}, {'title': 'Day 169: 6 HR post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '683.89', 'spread': '158.85', 'groupId': 'OG003'}]}]}, {'title': 'Day 176', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.97', 'spread': '132.41', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 1, 2, 4, 6 hours post-dose on days 1, 15, 29, 57, 85,113, 141, 169 and on days 2, 8, 92, and 176', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "The Part 1 pharmacokinetic (PK) analysis population included all randomized participants who received at least 1 dose of study treatment and had at least 1 postdose serum and/or cerebrospinal fluid (CSF) BIIB105 measurement in Part 1. 'Number analyzed (n)' signifies number of participants evaluable for this outcome measure (OM) at the specified timepoint."}, {'type': 'SECONDARY', 'title': 'Part 1: CSF Concentrations of BIIB105', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Cohort A: BIIB105 5 mg', 'description': 'Participants with ALS received 3 loading doses of BIIB105 5 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'OG001', 'title': 'Part 1: Cohort B: BIIB105 20 mg', 'description': 'Participants with ALS received 3 loading doses of BIIB105 20 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'OG002', 'title': 'Part 1: Cohorts C1+C2: BIIB105 60 mg', 'description': 'Participants with ALS (Cohort C1) and polyQ-ALS (Cohort C2) received 3 loading doses of BIIB105 60 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'OG003', 'title': 'Part 1: Cohorts D1 + D2: BIIB105 120 mg', 'description': 'Participants with ALS (Cohort D1) and polyQ-ALS (Cohort D2) received 3 loading doses of BIIB105 120 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.'}], 'classes': [{'title': 'Day 1 : Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG003'}]}]}, {'title': 'Day 15 : Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.93', 'spread': '41.54', 'groupId': 'OG000'}, {'value': '2.71', 'spread': '55.21', 'groupId': 'OG001'}, {'value': '5.75', 'spread': '62.33', 'groupId': 'OG002'}, {'value': '14.54', 'spread': '82.48', 'groupId': 'OG003'}]}]}, {'title': 'Day 29 : Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.53', 'spread': '33.52', 'groupId': 'OG000'}, {'value': '4.32', 'spread': '52.42', 'groupId': 'OG001'}, {'value': '11.53', 'spread': '49.38', 'groupId': 'OG002'}, {'value': '17.53', 'spread': '95.18', 'groupId': 'OG003'}]}]}, {'title': 'Day 57 : Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.32', 'spread': '28.96', 'groupId': 'OG000'}, {'value': '2.65', 'spread': '46.23', 'groupId': 'OG001'}, {'value': '4.82', 'spread': '59.33', 'groupId': 'OG002'}, {'value': '10.29', 'spread': '79.90', 'groupId': 'OG003'}]}]}, {'title': 'Day 85 : Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.37', 'spread': '30.35', 'groupId': 'OG000'}, {'value': '3.18', 'spread': '72.73', 'groupId': 'OG001'}, {'value': '6.50', 'spread': '36.23', 'groupId': 'OG002'}, {'value': '14.06', 'spread': '77.42', 'groupId': 'OG003'}]}]}, {'title': 'Day 92', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.01', 'spread': '30.62', 'groupId': 'OG000'}, {'value': '6.28', 'spread': '74.45', 'groupId': 'OG001'}, {'value': '25.51', 'spread': '66.26', 'groupId': 'OG002'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.08', 'spread': '86.41', 'groupId': 'OG003'}]}]}, {'title': 'Day 130', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.09', 'spread': '32.22', 'groupId': 'OG000'}, {'value': '2.45', 'spread': '57.06', 'groupId': 'OG001'}, {'value': '5.42', 'spread': '40.72', 'groupId': 'OG002'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.91', 'spread': '84.83', 'groupId': 'OG003'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.88', 'spread': '74.23', 'groupId': 'OG003'}]}]}, {'title': 'Day 175', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.16', 'spread': '54.77', 'groupId': 'OG000'}, {'value': '1.16', 'spread': '36.06', 'groupId': 'OG001'}, {'value': '2.68', 'spread': '46.05', 'groupId': 'OG002'}]}]}, {'title': 'Day 176', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.35', 'spread': '0.04', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose on Days 1, 15, 29, 57, 85, 113, 141, 169, and on days 92, 130, 175, and 176', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "The Part 1 PK analysis population included all randomized participants who received at least 1 dose of study treatment and had at least 1 postdose serum and/or CSF BIIB105 measurement in Part 1. 'Number analyzed (n)' signifies number of participants evaluable for this OM at the specified time point."}, {'type': 'SECONDARY', 'title': 'Part 1: Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUCinf)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Cohort A: BIIB105 5 mg', 'description': 'Participants with ALS received 3 loading doses of BIIB105 5 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'OG001', 'title': 'Part 1: Cohort B: BIIB105 20 mg', 'description': 'Participants with ALS received 3 loading doses of BIIB105 20 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'OG002', 'title': 'Part 1: Cohorts C1+C2: BIIB105 60 mg', 'description': 'Participants with ALS (Cohort C1) and polyQ-ALS (Cohort C2) received 3 loading doses of BIIB105 60 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'OG003', 'title': 'Part 1: Cohorts D1 + D2: BIIB105 120 mg', 'description': 'Participants with ALS (Cohort D1) and polyQ-ALS (Cohort D2) received 3 loading doses of BIIB105 120 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '934.22', 'spread': '52.89', 'groupId': 'OG000'}, {'value': '3546.89', 'spread': '53.50', 'groupId': 'OG001'}, {'value': '11258.45', 'spread': '14.57', 'groupId': 'OG002'}, {'value': '24466.44', 'spread': '30.24', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1', 'description': 'AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was reported following dose 1 as planned.', 'unitOfMeasure': 'Hour*nanogram per milliliter (h*ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "Part 1 PK analysis population included all randomized participants who received at least 1 dose of study treatment and had at least 1 postdose serum and/or CSF BIIB105 measurement in Part 1. 'Overall number of participants analyzed' signifies number of participants with data available for OM analysis."}, {'type': 'SECONDARY', 'title': 'Part 1: Area Under the Serum Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUClast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Cohort A: BIIB105 5 mg', 'description': 'Participants with ALS received 3 loading doses of BIIB105 5 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'OG001', 'title': 'Part 1: Cohort B: BIIB105 20 mg', 'description': 'Participants with ALS received 3 loading doses of BIIB105 20 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'OG002', 'title': 'Part 1: Cohorts C1+C2: BIIB105 60 mg', 'description': 'Participants with ALS (Cohort C1) and polyQ-ALS (Cohort C2) received 3 loading doses of BIIB105 60 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'OG003', 'title': 'Part 1: Cohorts D1 + D2: BIIB105 120 mg', 'description': 'Participants with ALS (Cohort D1) and polyQ-ALS (Cohort D2) received 3 loading doses of BIIB105 120 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '574.59', 'spread': '79.16', 'groupId': 'OG000'}, {'value': '3239.40', 'spread': '52.73', 'groupId': 'OG001'}, {'value': '11758.68', 'spread': '21.12', 'groupId': 'OG002'}, {'value': '24289.70', 'spread': '30.50', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1', 'description': 'AUClast was reported following dose 1 as planned.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "Part 1 PK analysis population included all randomized participants who received at least 1 dose of study treatment and had at least 1 postdose serum and/or CSF BIIB105 measurement in Part 1. 'Overall number of participants analyzed' signifies number of participants with data available for OM analysis."}, {'type': 'SECONDARY', 'title': 'Part 1: Maximum Observed Serum Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Cohort A: BIIB105 5 mg', 'description': 'Participants with ALS received 3 loading doses of BIIB105 5 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'OG001', 'title': 'Part 1: Cohort B: BIIB105 20 mg', 'description': 'Participants with ALS received 3 loading doses of BIIB105 20 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'OG002', 'title': 'Part 1: Cohorts C1+C2: BIIB105 60 mg', 'description': 'Participants with ALS (Cohort C1) and polyQ-ALS (Cohort C2) received 3 loading doses of BIIB105 60 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'OG003', 'title': 'Part 1: Cohorts D1 + D2: BIIB105 120 mg', 'description': 'Participants with ALS (Cohort D1) and polyQ-ALS (Cohort D2) received 3 loading doses of BIIB105 120 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '52.18', 'spread': '123.13', 'groupId': 'OG000'}, {'value': '227.80', 'spread': '73.20', 'groupId': 'OG001'}, {'value': '644.10', 'spread': '55.31', 'groupId': 'OG002'}, {'value': '1019.11', 'spread': '76.61', 'groupId': 'OG003'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '31.03', 'spread': '78.23', 'groupId': 'OG000'}, {'value': '165.37', 'spread': '118.45', 'groupId': 'OG001'}, {'value': '495.03', 'spread': '76.73', 'groupId': 'OG002'}, {'value': '1312.42', 'spread': '93.96', 'groupId': 'OG003'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '34.11', 'spread': '119.62', 'groupId': 'OG000'}, {'value': '164.15', 'spread': '101.46', 'groupId': 'OG001'}, {'value': '616.02', 'spread': '61.54', 'groupId': 'OG002'}, {'value': '1173.71', 'spread': '75.74', 'groupId': 'OG003'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '31.92', 'spread': '136.57', 'groupId': 'OG000'}, {'value': '94.60', 'spread': '75.30', 'groupId': 'OG001'}, {'value': '513.84', 'spread': '98.01', 'groupId': 'OG002'}, {'value': '1052.70', 'spread': '99.57', 'groupId': 'OG003'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '31.43', 'spread': '117.43', 'groupId': 'OG000'}, {'value': '168.38', 'spread': '59.96', 'groupId': 'OG001'}, {'value': '476.91', 'spread': '75.87', 'groupId': 'OG002'}, {'value': '1009.44', 'spread': '84.68', 'groupId': 'OG003'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '949.58', 'spread': '83.69', 'groupId': 'OG003'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1243.75', 'spread': '91.13', 'groupId': 'OG003'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '957.24', 'spread': '86.51', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1, 15, 29, 57, 85, 113, 141 and 169', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "Part 1 PK analysis population included all randomized participants who received at least 1 dose of study treatment and had at least 1 postdose serum and/or CSF BIIB105 measurement in Part 1. 'Number analyzed (n)' signifies number of participants evaluable for this OM at the specified timepoint."}, {'type': 'SECONDARY', 'title': 'Part 1: Time to Reach Maximum Observed Serum Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Cohort A: BIIB105 5 mg', 'description': 'Participants with ALS received 3 loading doses of BIIB105 5 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'OG001', 'title': 'Part 1: Cohort B: BIIB105 20 mg', 'description': 'Participants with ALS received 3 loading doses of BIIB105 20 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'OG002', 'title': 'Part 1: Cohorts C1+C2: BIIB105 60 mg', 'description': 'Participants with ALS (Cohort C1) and polyQ-ALS (Cohort C2) received 3 loading doses of BIIB105 60 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'OG003', 'title': 'Part 1: Cohorts D1 + D2: BIIB105 120 mg', 'description': 'Participants with ALS (Cohort D1) and polyQ-ALS (Cohort D2) received 3 loading doses of BIIB105 120 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '6'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '6'}, {'value': '5.8', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '23'}, {'value': '4.3', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '24'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '6'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '6'}, {'value': '5.9', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '6'}, {'value': '4.1', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '6'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '6'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '6'}, {'value': '4.2', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '6'}, {'value': '4.1', 'groupId': 'OG003', 'lowerLimit': '2', 'upperLimit': '6'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '6'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '6'}, {'value': '4.2', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '6'}, {'value': '4.5', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '6'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '6'}, {'value': '4.3', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '6'}, {'value': '5.8', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '6'}, {'value': '5.8', 'groupId': 'OG003', 'lowerLimit': '2', 'upperLimit': '6'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '6'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '6'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG003', 'lowerLimit': '1', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1, 15, 29, 57, 85, 113, 141 and 169', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "Part 1 PK analysis population included all randomized participants who received at least 1 dose of study treatment and had at least 1 postdose serum and/or CSF BIIB105 measurement in Part 1. 'Number analyzed (n)' signifies number of participants evaluable for this OM at the specified timepoint."}, {'type': 'SECONDARY', 'title': 'Part 1: Elimination Half-Life (t1/2) in Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Cohort A: BIIB105 5 mg', 'description': 'Participants with ALS received 3 loading doses of BIIB105 5 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'OG001', 'title': 'Part 1: Cohort B: BIIB105 20 mg', 'description': 'Participants with ALS received 3 loading doses of BIIB105 20 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'OG002', 'title': 'Part 1: Cohorts C1+C2: BIIB105 60 mg', 'description': 'Participants with ALS (Cohort C1) and polyQ-ALS (Cohort C2) received 3 loading doses of BIIB105 60 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'OG003', 'title': 'Part 1: Cohorts D1 + D2: BIIB105 120 mg', 'description': 'Participants with ALS (Cohort D1) and polyQ-ALS (Cohort D2) received 3 loading doses of BIIB105 120 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '23'}, {'value': '26.6', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '62'}, {'value': '41.7', 'groupId': 'OG002', 'lowerLimit': '33', 'upperLimit': '62'}, {'value': '39.8', 'groupId': 'OG003', 'lowerLimit': '22', 'upperLimit': '82'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1', 'description': 'Elimination half-life (t1/2) was reported following dose 1 as planned.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "Part 1 PK analysis population included all randomized participants who received at least 1 dose of study treatment and had at least 1 postdose serum and/or CSF BIIB105 measurement in Part 1. ''Overall number of participants (n)' signifies number of participants evaluable for this OM."}, {'type': 'SECONDARY', 'title': 'Part 1: Neurofilament Light Chain (NfL) Plasma Concentration Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Pooled Placebo 1+2', 'description': 'Participants with ALS and polyQ-ALS from Cohorts A, B, C1 and C2 received 3 loading doses of BIIB105-matched placebo, administered every 2 weeks (on Days 1, 15 and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks. Participants with ALS and polyQ-ALS from Cohorts D1 and D2 received 3 loading doses of BIIB105- matched placebo administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.'}, {'id': 'OG001', 'title': 'Part 1: Cohort A: BIIB105 5 mg', 'description': 'Participants with ALS received 3 loading doses of BIIB105 5 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'OG002', 'title': 'Part 1: Cohort B: BIIB105 20 mg', 'description': 'Participants with ALS received 3 loading doses of BIIB105 20 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'OG003', 'title': 'Part 1: Cohorts C1+C2: BIIB105 60 mg', 'description': 'Participants with ALS (Cohort C1) and polyQ-ALS (Cohort C2) received 3 loading doses of BIIB105 60 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'OG004', 'title': 'Part 1: Cohorts D1 + D2: BIIB105 120 mg', 'description': 'Participants with ALS (Cohort D1) and polyQ-ALS (Cohort D2) received 3 loading doses of BIIB105 120 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.'}], 'classes': [{'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.04', 'spread': '20.32', 'groupId': 'OG000'}, {'value': '1.05', 'spread': '8.47', 'groupId': 'OG001'}, {'value': '0.83', 'spread': '47.1', 'groupId': 'OG002'}, {'value': '1.06', 'spread': '11.23', 'groupId': 'OG003'}, {'value': '1.15', 'spread': '72.72', 'groupId': 'OG004'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.08', 'spread': '19.91', 'groupId': 'OG000'}, {'value': '0.95', 'spread': '14.63', 'groupId': 'OG001'}, {'value': '0.97', 'spread': '15.95', 'groupId': 'OG002'}, {'value': '1.08', 'spread': '20.43', 'groupId': 'OG003'}, {'value': '1.03', 'spread': '21.7', 'groupId': 'OG004'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.99', 'spread': '17.27', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '15.7', 'groupId': 'OG001'}, {'value': '0.98', 'spread': '26.4', 'groupId': 'OG002'}, {'value': '1.11', 'spread': '19.85', 'groupId': 'OG003'}, {'value': '0.99', 'spread': '19.62', 'groupId': 'OG004'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.06', 'spread': '19.95', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '21.77', 'groupId': 'OG004'}]}]}, {'title': 'Day 130 (A,B,C1,C2)/Day 141 (D1,D2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.09', 'spread': '20.46', 'groupId': 'OG000'}, {'value': '1.10', 'spread': '8.58', 'groupId': 'OG001'}, {'value': '0.92', 'spread': '40.79', 'groupId': 'OG002'}, {'value': '0.99', 'spread': '30.8', 'groupId': 'OG003'}, {'value': '1.03', 'spread': '41.35', 'groupId': 'OG004'}]}]}, {'title': 'Day 169 (A,B,C1,C2)/Day 175 (D1,D2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.10', 'spread': '23.67', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '22.58', 'groupId': 'OG001'}, {'value': '1.10', 'spread': '24.55', 'groupId': 'OG002'}, {'value': '1.08', 'spread': '29.73', 'groupId': 'OG003'}, {'value': '1.06', 'spread': '24.92', 'groupId': 'OG004'}]}]}, {'title': 'Day 214', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.07', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 29, 57, 85, 113, 130 (For cohorts A, B, C1 and C2)/141 (For cohorts D1 and D2), 169 (For cohorts A, B, C1 and C2)/175 (For cohorts D1 and D2) and 241', 'description': 'Plasma NfL ratio to baseline was reported in terms of geometric mean ratio.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "The Part 1 pharmacodynamic (PD) population included participants who received at least 1 dose of study treatment and have at least 1 available postdose evaluation of the respective PD endpoint in the study in Part 1. 'Number analyzed (n)' indicates the number of participants evaluable for the OM at the specified timepoint."}, {'type': 'SECONDARY', 'title': 'Integrated Part 1 and Part 2: CSF PK Concentration of BIIB105', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early-start BIIB105 120 mg', 'description': 'Participants from Cohorts D1 and D2 from the Part 1 FAS population who received BIIB105 120 mg in Part 1, who may or may not have continued their study treatment in Part 2 were included in this group.'}, {'id': 'OG001', 'title': 'Placebo/Delayed-start BIIB105 120 mg', 'description': 'Participants from Cohorts D1 and D2 from the Part 1 FAS population who received placebo in Part 1, who may or may not have rolled over to Part 2 and started active treatment with BIIB105 were included in this group.'}], 'classes': [{'title': 'Day 1 : Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.15', 'spread': '37.88', 'groupId': 'OG001'}]}]}, {'title': 'Day 15 : Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.54', 'spread': '82.48', 'groupId': 'OG000'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.04', 'groupId': 'OG000'}, {'value': '12.93', 'spread': '70.31', 'groupId': 'OG001'}]}]}, {'title': 'Day 29: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.53', 'spread': '95.18', 'groupId': 'OG000'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.62', 'spread': '93.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 57 : Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.29', 'spread': '79.90', 'groupId': 'OG000'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.72', 'spread': '49.08', 'groupId': 'OG001'}]}]}, {'title': 'Day 85 : Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.06', 'spread': '77.42', 'groupId': 'OG000'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.54', 'spread': '63.76', 'groupId': 'OG001'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.08', 'spread': '86.41', 'groupId': 'OG000'}, {'value': '20.70', 'spread': '56.82', 'groupId': 'OG001'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.91', 'spread': '84.83', 'groupId': 'OG000'}, {'value': '24.50', 'spread': '30.13', 'groupId': 'OG001'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.88', 'spread': '74.23', 'groupId': 'OG000'}, {'value': '19.32', 'spread': '36.08', 'groupId': 'OG001'}]}]}, {'title': 'Day 176', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.35', 'spread': '0.04', 'groupId': 'OG000'}]}]}, {'title': 'Day 197', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.88', 'spread': '57.69', 'groupId': 'OG000'}, {'value': '24.99', 'spread': '71.18', 'groupId': 'OG001'}]}]}, {'title': 'Day 210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.04', 'spread': '67.88', 'groupId': 'OG000'}]}]}, {'title': 'Day 225', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.14', 'spread': '63.21', 'groupId': 'OG000'}, {'value': '30.52', 'spread': '13.97', 'groupId': 'OG001'}]}]}, {'title': 'Day 253', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.54', 'spread': '62.86', 'groupId': 'OG000'}, {'value': '21.68', 'spread': '70.34', 'groupId': 'OG001'}]}]}, {'title': 'Day 281', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.51', 'spread': '73.96', 'groupId': 'OG000'}, {'value': '23.79', 'spread': '8.69', 'groupId': 'OG001'}]}]}, {'title': 'Day 309', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.14', 'spread': '63.54', 'groupId': 'OG000'}, {'value': '30.47', 'spread': '13.01', 'groupId': 'OG001'}]}]}, {'title': 'Day 337', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.34', 'spread': '71.84', 'groupId': 'OG000'}, {'value': '22.11', 'spread': '16.80', 'groupId': 'OG001'}]}]}, {'title': 'Day 365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.16', 'spread': '62.35', 'groupId': 'OG000'}]}]}, {'title': 'Day 393', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.56', 'spread': '31.29', 'groupId': 'OG000'}, {'value': '15.36', 'spread': '13.95', 'groupId': 'OG001'}]}]}, {'title': 'Day 420', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.84', 'spread': '42.82', 'groupId': 'OG000'}, {'value': '21.91', 'groupId': 'OG001'}]}]}, {'title': 'Day 448', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.53', 'spread': '40.75', 'groupId': 'OG000'}, {'value': '28.43', 'spread': 'NA', 'comment': 'Geometric coefficient of variation is not estimable due to less number of participants.', 'groupId': 'OG001'}]}]}, {'title': 'Day 476', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.87', 'spread': '28.29', 'groupId': 'OG000'}, {'value': '25.95', 'spread': 'NA', 'comment': 'Geometric coefficient of variation is not estimable due to less number of participants.', 'groupId': 'OG001'}]}]}, {'title': 'Day 504', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.24', 'spread': '38.06', 'groupId': 'OG000'}]}]}, {'title': 'Day 532', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.73', 'spread': '44.19', 'groupId': 'OG000'}]}]}, {'title': 'Day 560', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.42', 'spread': '36.82', 'groupId': 'OG000'}]}]}, {'title': 'Day 588', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.26', 'spread': '68.00', 'groupId': 'OG000'}]}]}, {'title': 'Day 616', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.69', 'spread': '109.22', 'groupId': 'OG000'}]}]}, {'title': 'Day 644', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.15', 'spread': '39.95', 'groupId': 'OG000'}]}]}, {'title': 'Day 672', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.75', 'spread': '48.18', 'groupId': 'OG000'}]}]}, {'title': 'Day 700', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.85', 'spread': '1.63', 'groupId': 'OG000'}]}]}, {'title': 'Day 726', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.22', 'groupId': 'OG000'}]}]}, {'title': 'Day 728', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.28', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose on Days 1,15,29,57,85 and on Days 1,15,29,57,85,113,141,169.176,197,210,225,253,281,309,337,365,393,420,448,476,504,532,560,588,616,644,672,700,726,728', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Integrated Part 1 \\& 2=Part 1 PK population.Overall number of participants analyzed=number of participants evaluable for OM analysis.Number analyzed=number of participants evaluable at specified timepoint.Assessment was planned upto Day 1093 however,no assessments were conducted after Day 729 due to early termination.Treatment groups for integrated analysis of Parts 1 \\& 2 were planned for Early-start BIIB105 120 mg \\& Placebo/Delayed-start BIIB105,\\& results are reported for these treatment groups.'}, {'type': 'SECONDARY', 'title': 'Integrated Part 1 and Part 2: Serum Concentration of BIIB105', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early-start BIIB105 120 mg', 'description': 'Participants from Cohorts D1 and D2 from the Part 1 FAS population who received BIIB105 120 mg in Part 1, who may or may not have continued their study treatment in Part 2 were included in this group.'}, {'id': 'OG001', 'title': 'Placebo/Delayed-start BIIB105 120 mg', 'description': 'Participants from Cohorts D1 and D2 from the Part 1 FAS population who received placebo in Part 1, who may or may not have rolled over to Part 2 and started active treatment with BIIB105 were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data were not estimable due to values being below the lower limit of quantification', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data were not estimable due to values being below the lower limit of quantification', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Up to Day 176', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Assessments were planned upto Day 1009 for this OM;however no assessments were conducted after Day 176 due to early termination.Serum concentrations of BIIB105 were not estimable for Integrated Parts 1 \\& 2.Data collected for serum PK concentrations for Parts 1 \\& 2 are reported in OM #3 and #20(post-hoc)respectively.Treatment groups for integrated analysis of Parts 1 \\& 2 were planned for Early-start BIIB105 120 mg \\& Placebo/Delayed-start BIIB105,\\& results are reported for these treatment groups.'}, {'type': 'SECONDARY', 'title': 'Integrated Part 1 and Part 2: Neurofilament Light Chain (NfL) Plasma Concentration Ratio to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early-start BIIB105 120 mg', 'description': 'Participants from Cohorts D1 and D2 from the Part 1 FAS population who received BIIB105 120 mg in Part 1, who may or may not have continued their study treatment in Part 2 were included in this group.'}, {'id': 'OG001', 'title': 'Placebo/Delayed-start BIIB105 120 mg', 'description': 'Participants from Cohorts D1 and D2 from the Part 1 FAS population who received placebo in Part 1, who may or may not have rolled over to Part 2 and started active treatment with BIIB105 were included in this group.'}], 'classes': [{'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.15', 'spread': '72.72', 'groupId': 'OG000'}, {'value': '1.03', 'spread': '22.35', 'groupId': 'OG001'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.03', 'spread': '21.7', 'groupId': 'OG000'}, {'value': '1.11', 'spread': '18.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.99', 'spread': '19.62', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '18.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.01', 'spread': '21.77', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '19.95', 'groupId': 'OG001'}]}]}, {'title': 'Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.03', 'spread': '41.35', 'groupId': 'OG000'}, {'value': '1.10', 'spread': '20.84', 'groupId': 'OG001'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.06', 'spread': '24.92', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '20.33', 'groupId': 'OG001'}]}]}, {'title': 'Day 197', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.08', 'spread': '28.28', 'groupId': 'OG000'}, {'value': '1.08', 'spread': '23.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 225', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.12', 'spread': '38.42', 'groupId': 'OG000'}, {'value': '1.12', 'spread': '31.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 253', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.15', 'spread': '28.4', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '27.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 281', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.14', 'spread': '26.57', 'groupId': 'OG000'}, {'value': '1.18', 'spread': '21.26', 'groupId': 'OG001'}]}]}, {'title': 'Day 309', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.07', 'spread': '31.81', 'groupId': 'OG000'}, {'value': '1.09', 'spread': '24.46', 'groupId': 'OG001'}]}]}, {'title': 'Day 337', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.05', 'spread': '38.67', 'groupId': 'OG000'}, {'value': '1.18', 'spread': '23.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 365', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.99', 'spread': '32.42', 'groupId': 'OG000'}, {'value': '1.20', 'spread': '29.59', 'groupId': 'OG001'}]}]}, {'title': 'Day 393', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.95', 'spread': '48.05', 'groupId': 'OG000'}, {'value': '1.26', 'spread': '24.88', 'groupId': 'OG001'}]}]}, {'title': 'Day 421', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.92', 'spread': '36.61', 'groupId': 'OG000'}, {'value': '1.21', 'spread': '58.82', 'groupId': 'OG001'}]}]}, {'title': 'Day 449', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.82', 'spread': '28.9', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '32.94', 'groupId': 'OG001'}]}]}, {'title': 'Day 477', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.85', 'spread': '23.15', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '32.52', 'groupId': 'OG001'}]}]}, {'title': 'Day 505', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.77', 'spread': '25.18', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '46.94', 'groupId': 'OG001'}]}]}, {'title': 'Day 533', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.78', 'spread': '14.58', 'groupId': 'OG000'}, {'value': '1.15', 'spread': '32.24', 'groupId': 'OG001'}]}]}, {'title': 'Day 561', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.65', 'spread': '14.63', 'groupId': 'OG000'}]}]}, {'title': 'Day 589', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.77', 'spread': '39.28', 'groupId': 'OG000'}, {'value': '0.90', 'spread': '23.38', 'groupId': 'OG001'}]}]}, {'title': 'Day 617', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.80', 'spread': '38.48', 'groupId': 'OG000'}, {'value': '0.70', 'groupId': 'OG001'}]}]}, {'title': 'Day 645', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.76', 'spread': '52.68', 'groupId': 'OG000'}]}]}, {'title': 'Day 673', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.66', 'spread': '30.22', 'groupId': 'OG000'}]}]}, {'title': 'Day 701', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.54', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449, 477, 505, 533, 561, 589, 617, 645, 673, 701', 'description': 'Plasma NfL ratio to baseline was reported in terms of geometric mean ratio.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Integrated Parts 1 and 2=Part 1 PD population. Number analyzed indicates the number of participants evaluable for the OM at the specified timepoint. The treatment groups for the integrated analysis of Part 1 and Part 2 were planned for Early-start BIIB105 120 mg and Placebo/Delayed-start BIIB105, and results are reported for these treatment groups.'}, {'type': 'SECONDARY', 'title': 'Integrated Part 1 and Part 2: Change From Baseline in Percent Predicted Slow Vital Capacity (SVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early-start BIIB105 120 mg', 'description': 'Participants from Cohorts D1 and D2 from the Part 1 FAS population who received BIIB105 120 mg in Part 1, who may or may not have continued their study treatment in Part 2 were included in this group.'}, {'id': 'OG001', 'title': 'Placebo/Delayed-start BIIB105 120 mg', 'description': 'Participants from Cohorts D1 and D2 from the Part 1 FAS population who received placebo in Part 1, who may or may not have rolled over to Part 2 and started active treatment with BIIB105 were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.49', 'spread': '4.093', 'groupId': 'OG000'}, {'value': '-14.41', 'spread': '7.133', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.9924', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-15.47', 'ciUpperLimit': '15.32', 'pValueComment': 'ANCOVA model included: treatment as a fixed effect and adjusted for the following covariates: baseline disease duration since symptom onset, baseline percent predicted SVC, baseline plasma NfL, and use of riluzole or edaravone.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.84', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 281', 'description': 'Vital capacity was measured by means of the slow vital capacity (SVC) test using a facemask with the participant sitting upright. SVC was determined by performing at least 3 trials. If the difference between the two highest values of the three trials was ≥10%, then up to 5 trials were performed. The highest percent predicted SVC value at each visit was used for the analysis. Here, baseline is defined as Part 1 day 1 value prior to the study drug. As specified in SAP, change from baseline at Week 40 (Day 281) in least square means and corresponding standard errors was summarized using the analysis of covariance (ANCOVA) model. Negative change from baseline indicates decrease in lung function.', 'unitOfMeasure': 'percent predicted', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Integrated data for Part 1 and Part 2 was analyzed based on the clinical function population defined for Part 1. The Part 1 clinical function population included participants from the FAS population who have at least 1 postdose measurement in Part 1. The treatment groups for the integrated analysis of Part 1 and Part 2 were planned for Early-start BIIB105 120 mg and Placebo/Delayed-start BIIB105, and results are reported for these treatment groups.'}, {'type': 'SECONDARY', 'title': 'Integrated Part 1 and Part 2: Change From Baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early-start BIIB105 120 mg', 'description': 'Participants from Cohorts D1 and D2 from the Part 1 FAS population who received BIIB105 120 mg in Part 1, who may or may not have continued their study treatment in Part 2 were included in this group.'}, {'id': 'OG001', 'title': 'Placebo/Delayed-start BIIB105 120 mg', 'description': 'Participants from Cohorts D1 and D2 from the Part 1 FAS population who received placebo in Part 1, who may or may not have rolled over to Part 2 and started active treatment with BIIB105 were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.46', 'spread': '1.105', 'groupId': 'OG000'}, {'value': '-8.26', 'spread': '1.819', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.9203', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-4.14', 'ciUpperLimit': '3.74', 'pValueComment': 'ANCOVA model included: treatment as a fixed effect and adjusted for the following covariates: baseline disease duration since symptom onset, baseline percent predicted SVC, baseline plasma NfL, and use of riluzole or edaravone.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.01', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 281', 'description': 'The ALSFRS-R is a questionnaire that measured degree of impairment in 4 functional domains: respiratory function, bulbar function, gross motor skills, and fine motor skills. Each domain consists of 3 items, each scored from 0 to 4, with higher scores representing better function. Each domain score can have maximum score of 12 calculated as the sum of scores of 3 items for that domain and the total possible score for ALSFRS-R is 48. The total score is the sum of the 4 functional domain scores or all individual item scores if no missing item scores are present. Here, baseline is defined as Part 1 day 1 value prior to the study drug Negative change from baseline indicates disease progression. As specified in SAP change from baseline at Week 40 (Day 281) in least square means and corresponding standard errors was summarized using the ANCOVA model.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Integrated data for Part 1 and Part 2 was analyzed based on the clinical function population defined for Part 1. The Part 1 clinical function population included participants from the FAS population who have at least 1 postdose measurement in Part 1. The treatment groups for the integrated analysis of Part 1 and Part 2 were planned for Early-start BIIB105 120 mg and Placebo/Delayed-start BIIB105, and results are reported for these treatment groups.'}, {'type': 'SECONDARY', 'title': 'Integrated Part 1 and Part 2: Change From Baseline in Muscle Strength as Measured by Handheld Dynamometry (HHD) Megascore', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early-start BIIB105 120 mg', 'description': 'Participants from Cohorts D1 and D2 from the Part 1 FAS population who received BIIB105 120 mg in Part 1, who may or may not have continued their study treatment in Part 2 were included in this group.'}, {'id': 'OG001', 'title': 'Placebo/Delayed-start BIIB105 120 mg', 'description': 'Participants from Cohorts D1 and D2 from the Part 1 FAS population who received placebo in Part 1, who may or may not have rolled over to Part 2 and started active treatment with BIIB105 were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.407', 'spread': '0.3918', 'groupId': 'OG000'}, {'value': '-0.439', 'spread': '0.4406', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.1069', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '0.04', 'pValueComment': 'ANCOVA model included: treatment as a fixed effect and adjusted for the following covariates: baseline disease duration since symptom onset, baseline percent predicted SVC, baseline plasma NfL, and use of riluzole or edaravone.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 281', 'description': 'Quantitative muscle strength was evaluated using HHD, which tested the isometric strength of multiple muscles using standard participant positioning. Approximately 8 muscle groups were examined (per each side) in both upper and lower extremities. The muscle strength values were normalized to Z scores as (post-baseline measurements -mean)/SD and averaged to provide HHD overall megascore. The overall megascore was created by averaging Z scores, if no more than 14 (≤ 14) measures are missing. A Z-score (also called a standard score) is a way to describe how far and in what direction a data point is from the mean of the dataset (in this case, positive values indicate strength and negative values indicate weakness). A Z-score of 0 indicates the population mean, and a positive score indicates muscle strength. A negative change from baseline indicated decreased muscle strength.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Integrated data for Part 1 and Part 2 was analyzed based on the clinical function population defined for Part 1. The Part 1 clinical function population included participants from the FAS population who have at least 1 postdose measurement in Part 1. The treatment groups for the integrated analysis of Part 1 and Part 2 were planned for Early-start BIIB105 120 mg and Placebo/Delayed-start BIIB105, and results are reported for these treatment groups.'}, {'type': 'SECONDARY', 'title': 'Integrated Part 1 and Part 2: Time to Death or Permanent Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early-start BIIB105 120 mg', 'description': 'Participants from Cohorts D1 and D2 from the Part 1 FAS population who received BIIB105 120 mg in Part 1, who may or may not have continued their study treatment in Part 2 were included in this group.'}, {'id': 'OG001', 'title': 'Placebo/Delayed-start BIIB105 120 mg', 'description': 'Participants from Cohorts D1 and D2 from the Part 1 FAS population who received placebo in Part 1, who may or may not have rolled over to Part 2 and started active treatment with BIIB105 were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and 95% confidence interval (CI) were not estimable due to low number events of permanent ventilation or death.', 'groupId': 'OG000', 'lowerLimit': '72.7', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% confidence interval (CI) were not estimable due to low number events of permanent ventilation or death.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '=0.1003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.29', 'ciLowerLimit': '0.433', 'ciUpperLimit': '42.587', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Log rank test stratified by median baseline plasma NfL'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to Day 1184', 'description': "Time to death or permanent ventilation is defined as the time from first dose to death or permanent ventilation ( ≥ 22 hours of mechanical ventilation \\[invasive or noninvasive\\] per day for ≥ 21 consecutive days), whichever comes first. Participants who did not meet the endpoint definition were censored on the date of participant's last contact in Part 1 or Part 2. Time to death or permanent ventilation data was summarized using Kaplan-Meier curves based on randomization in Part 1.", 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Integrated data for Part 1 and Part 2 was analyzed based on the FAS population defined for Part 1. Part 1 FAS population included all randomized participants who received at least 1 dose of study treatment in Part 1 and 2. The treatment groups for the integrated analysis of Part 1 and Part 2 were planned for Early-start BIIB105 120 mg and Placebo/Delayed-start BIIB105, and results are reported for these treatment groups.'}, {'type': 'SECONDARY', 'title': 'Integrated Parts 1 and 2: Time to Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early-start BIIB105 120 mg', 'description': 'Participants from Cohorts D1 and D2 from the Part 1 FAS population who received BIIB105 120 mg in Part 1, who may or may not have continued their study treatment in Part 2 were included in this group.'}, {'id': 'OG001', 'title': 'Placebo/Delayed-start BIIB105 120 mg', 'description': 'Participants from Cohorts D1 and D2 from the Part 1 FAS population who received placebo in Part 1, who may or may not have rolled over to Part 2 and started active treatment with BIIB105 were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and 95% CI were not estimable due to low number of events of death.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and 95% CI were not estimable due to low number of events of death.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '=0.1143', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Kaplan-Meier product limit method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to Day 1184', 'description': 'Time to death was defined as the time from first dose to death.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Integrated data for Part 1 and Part 2 was analyzed based on the FAS population defined for Part 1. Part 1 FAS population included all randomized participants who received at least 1 dose of study treatment in Part 1 and 2. The treatment groups for the integrated analysis of Part 1 and Part 2 were planned for Early-start BIIB105 120 mg and Placebo/Delayed-start BIIB105, and results are reported for these treatment groups.'}, {'type': 'SECONDARY', 'title': 'Integrated Part 1 and Part 2: Time to Death, Incorporating Post-Study Withdrawal or Study Completion Vital Status Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early-start BIIB105 120 mg', 'description': 'Participants from Cohorts D1 and D2 from the Part 1 FAS population who received BIIB105 120 mg in Part 1, who may or may not have continued their study treatment in Part 2 were included in this group.'}, {'id': 'OG001', 'title': 'Placebo/Delayed-start BIIB105 120 mg', 'description': 'Participants from Cohorts D1 and D2 from the Part 1 FAS population who received placebo in Part 1, who may or may not have rolled over to Part 2 and started active treatment with BIIB105 were included in this group.'}], 'timeFrame': 'Up to Day 1184', 'reportingStatus': 'POSTED', 'populationDescription': 'As per the changes to the protocol-specified analyses mentioned in the SAP, time to death, incorporating post-study withdrawal or study completion vital status data was not performed as post-study withdrawal vital status data was not collected at the time of this analysis. The treatment groups for the integrated analysis of Part 1 and Part 2 were planned for Early-start BIIB105 120 mg and Placebo/Delayed-start BIIB105, and results are reported for these treatment groups.'}, {'type': 'POST_HOC', 'title': 'Part 2: Serum Concentration of BIIB105', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: BIIB105 60 mg', 'description': 'Participants from cohorts A-C2, who received 5, 20 and 60 mg doses of BIIB105 and placebo in Part 1 and completed Week 25 (Day 175) visit in Part 1 received BIIB105 60 mg in Part 2.'}, {'id': 'OG001', 'title': 'Part 2: BIIB105 120 mg', 'description': 'Participants from Cohorts D1 and D2 who received 120 mg dose of BIIB105 and placebo in Part 1 and completed Week 25 (Day 176) visit in Part 1 received BIIB105 120 mg in Part 2.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '1.47', 'spread': '139.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.25', 'spread': '186.75', 'groupId': 'OG000'}, {'value': '3.50', 'spread': '151.48', 'groupId': 'OG001'}]}]}, {'title': 'Day 337', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.46', 'spread': '333.20', 'groupId': 'OG000'}, {'value': '2.50', 'spread': '95.95', 'groupId': 'OG001'}]}]}, {'title': 'Day 505', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.53', 'spread': '340.11', 'groupId': 'OG000'}, {'value': '8.54', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Day 673', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.89', 'spread': '164.41', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1, 169, 337, 505 and 673', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "The PK analysis population is defined as all randomized participants who received at least 1 dose of study treatment and have at least 1 postdose serum and/or CSF BIIB105 measurement. 'Number analyzed' indicates the number of participants evaluable at the specified time point."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1: Pooled Placebo 1+2', 'description': 'Participants with ALS and polyQ-ALS from Cohorts A, B, C1 and C2 received 3 loading doses of BIIB105-matched placebo, administered every 2 weeks (on Days 1, 15 and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks. Participants with ALS and polyQ-ALS from Cohorts D1 and D2 received 3 loading doses of BIIB105- matched placebo administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.'}, {'id': 'FG001', 'title': 'Part 1: Cohort A: BIIB105 5 Milligrams (mg)', 'description': 'Participants with ALS received 3 loading doses of BIIB105 5mg, intrathecally (IT), administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'FG002', 'title': 'Part 1: Cohort B: BIIB105 20 mg', 'description': 'Participants with ALS received 3 loading doses of BIIB105 20mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'FG003', 'title': 'Part 1: Cohorts C1+C2: BIIB105 60 mg', 'description': 'Participants with ALS (Cohort C1) and polyQ-ALS (Cohort C2) received 3 loading doses of BIIB105 60 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'FG004', 'title': 'Part 1: Cohorts D1 + D2: BIIB105 120 mg', 'description': 'Participants with ALS (Cohort D1) and polyQ-ALS (Cohort D2) received 3 loading doses of BIIB105 120 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.'}, {'id': 'FG005', 'title': 'Part 2: BIIB105 60 mg', 'description': 'Participants from cohorts A-C2, who received 5, 20 and 60 mg doses of BIIB105 and placebo in Part 1 and completed Week 25 (Day 175) visit in Part 1 received BIIB105 60 mg in Part 2.'}, {'id': 'FG006', 'title': 'Part 2: BIIB105 120 mg', 'description': 'Participants from Cohorts D1 and D2 who received 120 mg dose of BIIB105 and placebo in Part 1 and completed Week 25 (Day 176) visit in Part 1 received BIIB105 120 mg in Part 2.'}], 'periods': [{'title': 'Part 1: Double Blinded Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '48'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '34'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '14'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Disease Progression - As Defined by the Protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'SubjectWithdrawal-VisitBurden/SchedulingConflict', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject - Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Part 2: Open Label Period', 'milestones': [{'type': 'STARTED', 'comment': 'Not all participants that completed Part 1 started Part 2.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '19'}, {'groupId': 'FG006', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '19'}, {'groupId': 'FG006', 'numSubjects': '51'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Disease Progression - As Defined by the Protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '6'}]}, {'type': 'Lack of Efficacy - Based on Subject Perception', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '35'}]}, {'type': 'SubjectWithdrawal-VisitBurden/SchedulingConflict', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject - Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants diagnosed with amyotrophic lateral sclerosis (ALS) and ALS associated with ataxin-2 (ATXN2) polyCAG expansion (polyQALS) took part in the study at investigational sites in the United States, Netherlands, Canada and Italy from 28 September 2020 to 13 August 2024.', 'preAssignmentDetails': "A total of 99 participants were randomized in Part 1 (placebo-controlled) of study to receive BIIB105 or placebo, of which 80 participants completed Part 1. A total of 70 eligible participants who completed Part 1 were enrolled into Part 2 (open-label) of study to receive BIIB105. Part 2 of study was terminated early based on Sponsor's decision."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}, {'value': '99', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: Pooled Placebo 1+2', 'description': 'Participants with ALS and polyQ-ALS from Cohorts A, B, C1 and C2 received 3 loading doses of BIIB105-matched placebo, administered every 2 weeks (on Days 1, 15 and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks. Participants with ALS and polyQ-ALS from Cohorts D1 and D2 received 3 loading doses of BIIB105- matched placebo administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.'}, {'id': 'BG001', 'title': 'Part 1: Cohort A: BIIB105 5 mg', 'description': 'Participants with ALS received 3 loading doses of BIIB105 5 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'BG002', 'title': 'Part 1: Cohort B: BIIB105 20 mg', 'description': 'Participants with ALS received 3 loading doses of BIIB105 20 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'BG003', 'title': 'Part 1: Cohorts C1+C2: BIIB105 60 mg', 'description': 'Participants with ALS (Cohort C1) and polyQ-ALS (Cohort C2) received 3 loading doses of BIIB105 60 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 2 maintenance doses administered once every 4 weeks (on Days 57 and 85), for a total of 5 doses over approximately 13 weeks.'}, {'id': 'BG004', 'title': 'Part 1: Cohorts D1 + D2: BIIB105 120 mg', 'description': 'Participants with ALS (Cohort D1) and polyQ-ALS (Cohort D2) received 3 loading doses of BIIB105 120 mg, IT, administered every 2 weeks (on Days 1, 15, and 29), followed by 5 maintenance doses administered once every 4 weeks (on Days 57, 85, 113, 141, and 169), for a total of 8 doses over approximately 25 weeks.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.9', 'spread': '11.15', 'groupId': 'BG000'}, {'value': '60.5', 'spread': '5.72', 'groupId': 'BG001'}, {'value': '49.3', 'spread': '17.84', 'groupId': 'BG002'}, {'value': '53.3', 'spread': '12.77', 'groupId': 'BG003'}, {'value': '57.7', 'spread': '11.45', 'groupId': 'BG004'}, {'value': '57.5', 'spread': '11.83', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}, {'value': '68', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}, {'value': '88', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '00', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}, {'value': '83', 'groupId': 'BG005'}]}, {'title': 'Multiple', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Not reported due to confidentiality regulations', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The part 1 full analysis set (FAS) population included all randomized participants who received at least 1 dose of study treatment in Part 1.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-07', 'size': 6578855, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-12T09:54', 'hasProtocol': True}, {'date': '2024-09-05', 'size': 2634716, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-08-12T09:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'whyStopped': "Sponsor's decision", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2020-07-30', 'resultsFirstSubmitDate': '2025-08-12', 'studyFirstSubmitQcDate': '2020-07-30', 'lastUpdatePostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-23', 'studyFirstPostDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'From first dose of the study drug in Part 1 up to end of follow up period in Part 1 (up to Day 260)', 'description': 'An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event. A TEAE/TESAE was defined as any AE/SAE with an onset date that is on or after the first dose of study drug or any pre-existing condition that has worsened in severity after the first dose of study drug.'}, {'measure': 'Part 2: Number of Participants With TEAEs and TESAEs', 'timeFrame': 'From first dose of the study in Part 2 up to end of follow up period in Part 2 (up to Day 1184)', 'description': 'An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event. A TEAE/TESAE was defined as any AE/SAE with an onset date that is on or after the first dose of study drug or any pre-existing condition that has worsened in severity after the first dose of study drug.'}], 'secondaryOutcomes': [{'measure': 'Part 1: Serum Concentrations of BIIB105', 'timeFrame': 'Pre-dose and 1, 2, 4, 6 hours post-dose on days 1, 15, 29, 57, 85,113, 141, 169 and on days 2, 8, 92, and 176'}, {'measure': 'Part 1: CSF Concentrations of BIIB105', 'timeFrame': 'Pre-dose on Days 1, 15, 29, 57, 85, 113, 141, 169, and on days 92, 130, 175, and 176'}, {'measure': 'Part 1: Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUCinf)', 'timeFrame': 'Day 1', 'description': 'AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was reported following dose 1 as planned.'}, {'measure': 'Part 1: Area Under the Serum Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUClast)', 'timeFrame': 'Day 1', 'description': 'AUClast was reported following dose 1 as planned.'}, {'measure': 'Part 1: Maximum Observed Serum Concentration (Cmax)', 'timeFrame': 'Days 1, 15, 29, 57, 85, 113, 141 and 169'}, {'measure': 'Part 1: Time to Reach Maximum Observed Serum Concentration (Tmax)', 'timeFrame': 'Days 1, 15, 29, 57, 85, 113, 141 and 169'}, {'measure': 'Part 1: Elimination Half-Life (t1/2) in Serum', 'timeFrame': 'Day 1', 'description': 'Elimination half-life (t1/2) was reported following dose 1 as planned.'}, {'measure': 'Part 1: Neurofilament Light Chain (NfL) Plasma Concentration Ratio to Baseline', 'timeFrame': 'Days 29, 57, 85, 113, 130 (For cohorts A, B, C1 and C2)/141 (For cohorts D1 and D2), 169 (For cohorts A, B, C1 and C2)/175 (For cohorts D1 and D2) and 241', 'description': 'Plasma NfL ratio to baseline was reported in terms of geometric mean ratio.'}, {'measure': 'Integrated Part 1 and Part 2: CSF PK Concentration of BIIB105', 'timeFrame': 'Predose on Days 1,15,29,57,85 and on Days 1,15,29,57,85,113,141,169.176,197,210,225,253,281,309,337,365,393,420,448,476,504,532,560,588,616,644,672,700,726,728'}, {'measure': 'Integrated Part 1 and Part 2: Serum Concentration of BIIB105', 'timeFrame': 'Up to Day 176'}, {'measure': 'Integrated Part 1 and Part 2: Neurofilament Light Chain (NfL) Plasma Concentration Ratio to Baseline', 'timeFrame': 'Days 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449, 477, 505, 533, 561, 589, 617, 645, 673, 701', 'description': 'Plasma NfL ratio to baseline was reported in terms of geometric mean ratio.'}, {'measure': 'Integrated Part 1 and Part 2: Change From Baseline in Percent Predicted Slow Vital Capacity (SVC)', 'timeFrame': 'Baseline, Day 281', 'description': 'Vital capacity was measured by means of the slow vital capacity (SVC) test using a facemask with the participant sitting upright. SVC was determined by performing at least 3 trials. If the difference between the two highest values of the three trials was ≥10%, then up to 5 trials were performed. The highest percent predicted SVC value at each visit was used for the analysis. Here, baseline is defined as Part 1 day 1 value prior to the study drug. As specified in SAP, change from baseline at Week 40 (Day 281) in least square means and corresponding standard errors was summarized using the analysis of covariance (ANCOVA) model. Negative change from baseline indicates decrease in lung function.'}, {'measure': 'Integrated Part 1 and Part 2: Change From Baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) Score', 'timeFrame': 'Baseline, Day 281', 'description': 'The ALSFRS-R is a questionnaire that measured degree of impairment in 4 functional domains: respiratory function, bulbar function, gross motor skills, and fine motor skills. Each domain consists of 3 items, each scored from 0 to 4, with higher scores representing better function. Each domain score can have maximum score of 12 calculated as the sum of scores of 3 items for that domain and the total possible score for ALSFRS-R is 48. The total score is the sum of the 4 functional domain scores or all individual item scores if no missing item scores are present. Here, baseline is defined as Part 1 day 1 value prior to the study drug Negative change from baseline indicates disease progression. As specified in SAP change from baseline at Week 40 (Day 281) in least square means and corresponding standard errors was summarized using the ANCOVA model.'}, {'measure': 'Integrated Part 1 and Part 2: Change From Baseline in Muscle Strength as Measured by Handheld Dynamometry (HHD) Megascore', 'timeFrame': 'Baseline, Day 281', 'description': 'Quantitative muscle strength was evaluated using HHD, which tested the isometric strength of multiple muscles using standard participant positioning. Approximately 8 muscle groups were examined (per each side) in both upper and lower extremities. The muscle strength values were normalized to Z scores as (post-baseline measurements -mean)/SD and averaged to provide HHD overall megascore. The overall megascore was created by averaging Z scores, if no more than 14 (≤ 14) measures are missing. A Z-score (also called a standard score) is a way to describe how far and in what direction a data point is from the mean of the dataset (in this case, positive values indicate strength and negative values indicate weakness). A Z-score of 0 indicates the population mean, and a positive score indicates muscle strength. A negative change from baseline indicated decreased muscle strength.'}, {'measure': 'Integrated Part 1 and Part 2: Time to Death or Permanent Ventilation', 'timeFrame': 'Baseline up to Day 1184', 'description': "Time to death or permanent ventilation is defined as the time from first dose to death or permanent ventilation ( ≥ 22 hours of mechanical ventilation \\[invasive or noninvasive\\] per day for ≥ 21 consecutive days), whichever comes first. Participants who did not meet the endpoint definition were censored on the date of participant's last contact in Part 1 or Part 2. Time to death or permanent ventilation data was summarized using Kaplan-Meier curves based on randomization in Part 1."}, {'measure': 'Integrated Parts 1 and 2: Time to Death', 'timeFrame': 'Baseline up to Day 1184', 'description': 'Time to death was defined as the time from first dose to death.'}, {'measure': 'Integrated Part 1 and Part 2: Time to Death, Incorporating Post-Study Withdrawal or Study Completion Vital Status Data', 'timeFrame': 'Up to Day 1184'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Amyotrophic Lateral Sclerosis']}, 'referencesModule': {'references': [{'pmid': '36288714', 'type': 'DERIVED', 'citation': 'Kim G, Nakayama L, Blum JA, Akiyama T, Boeynaems S, Chakraborty M, Couthouis J, Tassoni-Tsuchida E, Rodriguez CM, Bassik MC, Gitler AD. Genome-wide CRISPR screen reveals v-ATPase as a drug target to lower levels of ALS protein ataxin-2. Cell Rep. 2022 Oct 25;41(4):111508. doi: 10.1016/j.celrep.2022.111508.'}], 'seeAlsoLinks': [{'url': 'https://www.biogentriallink.com/en-us/home.html', 'label': 'Biogen Trial Link'}]}, 'descriptionModule': {'briefSummary': 'The ALSpire Study is a clinical trial evaluating the investigational drug BIIB105 in adults living with amyotrophic lateral sclerosis (ALS).\n\nThe ALSpire Study consists of two parts:\n\n* Part 1: 6-month placebo-controlled study. During Part 1, participants are randomly assigned to receive either BIIB105 or placebo in a 3:1 or 2:1 ratio (depending on the participant\'s assigned Cohort).\n* Part 2: up to 3-year long-term open-label extension. During Part 2, all participants receive BIIB105.\n\nThe objectives of the study are to evaluate:\n\n* The safety and tolerability of BIIB105 in people with ALS\n* What the body does to BIIB105 (also called "pharmacokinetics")\n* What BIIB105 does to the body (also called "pharmacodynamics")\n* Whether BIIB105 can slow the worsening of clinical function', 'detailedDescription': 'About BIIB105:\n\n\\- BIIB105 is an investigational drug designed to reduce the levels of a protein called ATXN2. It is administered intrathecally (via a procedure called lumbar puncture).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\nPart 1:\n\n* Ability of the participant to understand the purpose and risks of the study and indicate informed consent, and the ability of the participant or the participant's legally authorized representative, to provide signed and dated informed consent and authorization to use protected health information in accordance with national and local privacy regulations.\n* No known presence or family history of mutations in the superoxide dismutase 1 (SOD1) or fused in sarcoma (FUS) genes.\n* Participants in Cohorts A, B, C1 and D1, must meet the laboratory-supported probable, probable, or definite criteria for diagnosing ALS according to the World Federation of Neurology El Escorial criteria (revised according to the Airlie House Conference 1998 \\[Brooks 2000\\]). Participants in Cohort C2 and D2, must meet any of the prior conditions, but may also only meet clinically possible criteria for diagnosing ALS, or exhibit weakness attributable to ALS in the presence of ataxin-2 protein (ATXN2) intermediate repeats.\n* In participants in Cohorts C2 and D2, confirmed intermediate cytosine-adenine-guanine/cytosine-adenine-adenine (CAG/CAA) repeat expansion in the ataxin-2 (ATXN2) gene as defined by at least 1 allele carrying 30 to 33 CAG/CAA repeats.\n* Slow vital capacity (SVC) criteria:\n* In participants in Cohorts A, B, C1, and D1, SVC ≥60% of predicted value as adjusted for sex, age, and height (from the sitting position).\n* In participants in Cohort C2 and D2, SVC ≥50% of predicted value as adjusted for sex, age, and height (from the sitting position).\n* If taking riluzole, participant must be on a stable dose for ≥30 days prior to Day 1 and expected to remain at that dose until the final study visit, unless the Investigator determines that it should be discontinued for medical reasons, in which case it may not be restarted during the study.\n* Participants taking concomitant edaravone at study entry must be on a stable dose for ≥60 days prior to the first dose of study treatment (Day 1). Participants taking concomitant edaravone must be willing to continue with the same dose regimen throughout the study, unless the Investigator determines that edaravone should be discontinued for medical reasons, in which case it may not be restarted during the study. Edaravone may not be administered on dosing days of this study.\n* Screening values of coagulation parameters including platelet count, international normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (aPTT) should be within normal ranges.\n* Has an informant/caregiver who, in the Investigator's judgment, has frequent and sufficient contact with the participant as to be able to provide accurate information about the participant's cognitive and functional abilities at screening.\n\nPart 2:\n\n* Ability of the participant to understand the purpose and risks of the study and indicate informed consent, and the ability of the participant or the participant's legally authorized representative to provide signed and dated informed consent and authorization to use protected health information in accordance with national and local privacy regulations\n* Participants must have completed Study NCT04494256 Part 1 through Week 25 (Day 175 Visit for Cohorts A, B, C1, C2; Day 176 Visit for Cohorts D1, D2). This inclusion criterion does not apply to a participant if Part 1 was terminated by the Sponsor before the participant reached Week 25.\n* Participants from Cohorts A, B, C1, and C2 must have a washout of ≥16 weeks between the last dose of study treatment received in Study NCT04494256 Part 1 and the first dose of BIIB105 received in Study NCT04494256 Part 2. Participants from Cohorts D1 and D2 do not require a washout period.\n* If taking riluzole, participant must be on a stable dose for ≥30 days prior to Day 1 and expected to remain at that dose until the final study visit, unless the Investigator determines that it should be discontinued for medical reasons, in which case it may not be restarted during the study.\n* Participants taking concomitant edaravone at study entry must be on a stable dose for ≥60 days prior to the first dose of study treatment (Day 1). Participants taking concomitant edaravone must be willing to continue with the same dose regimen throughout the study, unless the Investigator determines that edaravone should be discontinued for medical reasons, in which case it may not be restarted during the study. Edaravone may not be administered on dosing days of this study.\n* Screening values of coagulation parameters including platelet count, INR, PT, and aPTT should be within normal ranges.\n\nKey Exclusion Criteria\n\nPart 1:\n\n* History or positive test result at Screening for human immunodeficiency virus (HIV).\n* Current hepatitis C infection.\n* Current hepatitis B infection.\n* History of alcohol or substance abuse ≤6 months of Screening that would limit participation in the study, as determined by the Investigator.\n* Current or anticipated need, in the opinion of the Investigator, of a diaphragm pacing system during the study period.\n* Presence of tracheostomy.\n* In participants from Cohorts A, B, C1, and D1, history of myocardial infarction, as determined by the Investigator.\n* In participants from Cohorts A, B, C1, and D1, poorly controlled type 1 or 2 diabetes mellitus defined as hemoglobin A1c (HbA1c) ≥8% during Screening.\n* In participants in Cohorts A, B, and C1, prescreening ALSFRS-R slope \\>-0.4 points/month, where prescreening ALSFRS-R slope is defined as: (ALSFRS-R score at Screening - 48) / (months from date of symptom onset to date of Screening). This criterion is not applicable for Cohorts C2, D1, and D2.\n* Treatment with another investigational drug (including investigational drugs for ALS through compassionate use programs) or biological agent within 1 month or 5 half-lives of study agent, whichever is longer, before Screening.\n* Treatment with an approved disease-modifying therapy for ALS other than riluzole or edaravone within 1 month or 5 half-lives of therapy, whichever is longer, before completion of screening.\n* Treatment with an antiplatelet or anticoagulant therapy that cannot safely be interrupted for lumbar puncture (LP) according to local standard of care and/or institutional guidelines, in the opinion of the Investigator or Prescriber.\n* Female participants who are pregnant or currently breastfeeding and those intending to become pregnant during the study.\n\nPart 2:\n\n* History or positive test result at Screening for HIV. If participants from Cohorts D1 and D2 who would seamlessly roll from Part 1 into Part 2 test positive for HIV during screening for Part 2 but are clinically asymptomatic, they may enroll in Part 2 at the discretion of the Investigator.\n* Current hepatitis C infection. If participants from Cohorts D1 and D2 who would seamlessly roll from Part 1 into Part 2 test positive for hepatitis C during screening for Part 2 but are clinically asymptomatic, they may enroll in Part 2 at the discretion of the Investigator.\n* Current hepatitis B infection. If participants from Cohorts D1 and D2 who would seamlessly roll from Part 1 into Part 2 test positive for hepatitis B during screening for Part 2 but are clinically asymptomatic, they may enroll in Part 2 at the discretion of the Investigator.\n* History of alcohol or substance abuse ≤ 6 months of Screening that would limit participation in the study, as determined by the Investigator.\n* Current or anticipated need, in the opinion of the Investigator, of a diaphragm pacing system during the study period.\n* In participants from Cohorts A, B, C1, and D1, history of myocardial infarction, as determined by the Investigator.\n* In participants from Cohorts A, B, C1, and D1, poorly controlled type 1 or 2 diabetes mellitus defined as HbA1c ≥8% during Screening.\n* Treatment with another investigational drug (including investigational drugs for ALS through compassionate use programs; excluding BIIB105) or biological agent within 1 month or 5 half-lives of study agent, whichever is longer, before Screening.\n* Treatment with an antiplatelet or anticoagulant therapy that cannot safely be interrupted for LP according to local standard of care and/or institutional guidelines, in the opinion of the Investigator or Prescriber.\n* Female participants who are pregnant or currently breastfeeding and those intending to become pregnant during the study.\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT04494256', 'acronym': 'ALSpire', 'briefTitle': 'A Study to Assess the Safety, Tolerability, and Effect on Disease Progression of BIIB105 in Participants With Amyotrophic Lateral Sclerosis (ALS) and Participants With the ALS Ataxin-2 (ATXN2) Genetic Mutation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Phase 1/2 Multiple-Ascending-Dose Study With a Long-Term Open-Label Extension to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Effect on Disease Progression of BIIB105 Administered Intrathecally to Adults With Amyotrophic Lateral Sclerosis With or Without Poly-CAG Expansion in the ATXN2 Gene', 'orgStudyIdInfo': {'id': '275AS101'}, 'secondaryIdInfos': [{'id': '2020-000207-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Cohort A', 'description': 'Participants with ALS will receive BIIB105 Dose 1, intrathecally (IT), as 3 loading doses on Day 1 and two later days, followed by two maintenance doses on two later days.', 'interventionNames': ['Drug: BIIB105']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Cohort B', 'description': 'Participants with ALS will receive BIIB105 Dose 2, IT, as 3 loading doses on Day 1 and two later days, followed by two maintenance doses on two later days.', 'interventionNames': ['Drug: BIIB105']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Cohort C1', 'description': 'Participants with ALS will receive BIIB105 Dose 3, IT, as 3 loading doses on Day 1 and two later days, followed by two maintenance doses on two later days.', 'interventionNames': ['Drug: BIIB105']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Cohort D1', 'description': 'Participants with ALS will receive BIIB105 Dose 4, IT, as 3 loading doses on Day 1 and two later days, followed by five maintenance doses on five later days.', 'interventionNames': ['Drug: BIIB105']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Cohort C2', 'description': 'Participants with polyQ-ALS will receive BIIB105 Dose 3, IT, as 3 loading doses on Day 1 and two later days, followed by two maintenance doses on two later days.', 'interventionNames': ['Drug: BIIB105']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Cohort D2', 'description': 'Participants with polyQ-ALS will receive BIIB105 Dose 4, IT, as 3 loading doses on Day 1 and two later days, followed by five maintenance doses on five later days.', 'interventionNames': ['Drug: BIIB105']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 1: Cohorts A-D2: Placebo', 'description': 'Participants with ALS and polyQ-ALS for Cohorts A, B, C1 and C2 will receive matching placebo to BIIB105 as 3 loading doses on Day 1 and two later days, followed by two maintenance doses on two later days, and participants with ALS and polyQ-ALS for Cohorts D1 and D2 will receive matching placebo to BIIB105 as 3 loading doses on Day 1 and two later days, followed by five maintenance doses on five later days.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Cohorts A-C2: Open-Label', 'description': 'Participants who complete Cohorts A, B, C1, and C2 will receive BIIB105 Dose 3, IT, as 3 loading doses on Day 1 and two later days, followed up to thirty-eight maintenance doses, on up to thirty-eight later days.', 'interventionNames': ['Drug: BIIB105']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Cohorts D1, D2: Open-Label', 'description': 'Participants who complete Cohorts D1 and D2 will have a blinded Loading Dose Period, during which those who received placebo in Part 1 will receive BIIB105 Dose 4, IT, as 3 loading doses on Day 1 and two later days, while those who received BIIB105 in Part 1 will receive 2 loading doses of BIIB105 Dose 4, IT, on Days 1 and one later day, and placebo on Day 15. After the blinded Loading Dose Period, participants will receive BIIB105 Dose 4 up to thirty-eight maintenance doses, on up to thirty-eight later days.', 'interventionNames': ['Drug: BIIB105']}], 'interventions': [{'name': 'BIIB105', 'type': 'DRUG', 'description': 'Administered as specified in the treatment arm.', 'armGroupLabels': ['Part 1: Cohort A', 'Part 1: Cohort B', 'Part 1: Cohort C1', 'Part 1: Cohort C2', 'Part 1: Cohort D1', 'Part 1: Cohort D2', 'Part 2: Cohorts A-C2: Open-Label', 'Part 2: Cohorts D1, D2: Open-Label']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered as specified in the treatment arm.', 'armGroupLabels': ['Part 1: Cohorts A-D2: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Barrow Neurological Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego Medical Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Neuromuscular Research Center', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital - Neuroscience Center -Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '20007-2113', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Health', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Emory Clinic', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21218', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'ALS Clinic - Department of Neurology, Neuromuscular Division, Johns Hopkins University, School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University, School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Neurological Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': 'H3A 2B4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Neurological Institute-Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Torino', 'country': 'Italy', 'facility': 'A.O.U. Città della salute e della scienza di Torino', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'UMC Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biogen'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'ipdSharing': 'YES', 'description': "In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}