Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-02-27 @ 10:39 AM
Study NCT ID:
NCT03842969
Status:
COMPLETED
Last Update Posted:
2023-08-31
First Post:
2019-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Open-Label Extension Study to Evaluate Long-Term Safety and Tolerability of RO7234292 (RG6042) in Huntington's Disease Participants Who Participated in Prior Roche and Genentech Sponsored Studies
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Australia', 'Chile', 'Japan', 'Poland'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006816', 'term': 'Huntington Disease'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D002819', 'term': 'Chorea'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718631', 'term': 'tominersen'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Approx. 3 Years', 'eventGroups': [{'id': 'EG000', 'title': 'Tominersen 120mg Q4W', 'description': 'Participants received open-label RO7234292 Q4W in this Arm', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 12, 'seriousNumAtRisk': 14, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Tominersen 120 mg Q8W', 'description': 'Participants received open-label RO7234292 Q8W in this Arm', 'otherNumAtRisk': 143, 'deathsNumAtRisk': 143, 'otherNumAffected': 99, 'seriousNumAtRisk': 143, 'deathsNumAffected': 0, 'seriousNumAffected': 17}, {'id': 'EG002', 'title': 'Tominersen 120 mg Q16W', 'description': 'Participants received open-label RO7234292 Q16W in this Arm', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 56, 'seriousNumAtRisk': 88, 'deathsNumAffected': 1, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Injection site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 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'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 50, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 110, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 145, 'numAffected': 21}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Foreign body aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Periorbital haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 15, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 15, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 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'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vitamin D decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 24, 'numAffected': 19}, 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'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Exostosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Fracture pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Limb mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 0, 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'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 25, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypotonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 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'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Suicidal behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Euthanasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Treatment Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tominersen 120mg Q4W', 'description': 'Participants received open-label RO7234292 Q4W in this Arm'}, {'id': 'OG001', 'title': 'Tominersen 120 mg Q8W', 'description': 'Participants received open-label RO7234292 Q8W in this Arm'}, {'id': 'OG002', 'title': 'Tominersen 120 mg Q16W', 'description': 'Participants received open-label RO7234292 Q16W in this Arm'}], 'classes': [{'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}, {'value': '83.9', 'groupId': 'OG001'}, {'value': '81.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Approximately 3 Years', 'description': 'The reported are the treatment-emergent AEs with an onset date up to 5 months after last study drug intake.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tominersen 120mg Q4W', 'description': 'Participants received open-label RO7234292 Q4W in this Arm'}, {'id': 'OG001', 'title': 'Tominersen 120 mg Q8W', 'description': 'Participants received open-label RO7234292 Q8W in this Arm'}, {'id': 'OG002', 'title': 'Tominersen 120mg Q16W', 'description': 'Participants received open-label RO7234292 Q16W in this Arm'}], 'classes': [{'title': 'Suicidal Ideation (1-5) -Wish to Be Dead', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Suicidal Ideation (1-5) -Non-specific Active Suicidal Thoughts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Suicidal Ideation (1-5) -Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Suicidal Ideation (1-5) -Active Suicidal Ideation with Intent to Act, without Specific Plan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Suicidal Ideation (1-5) -Active Suicidal Ideation with Specific Plan and Intent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Suicidal Behavior (6-10) -Preparatory Acts or Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Suicidal Behavior (6-10) -Aborted Attempt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Suicidal Behavior (6-10) -Interrupted Attempt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Suicidal Behavior (6-10) -Non-fatal Suicide Attempt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Suicidal Behavior (6-10) -Completed Suicide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Suicidal Ideation or Behavior (1-10)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Self-injurious Behavior without Suicidal Intent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Treatment-Emergent Suicidal Ideation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Treatment-Emergent Serious Suicidal Ideation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Emergence of Serious Suicidal Ideation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Emergence of Suicidal Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 3 Years', 'description': 'C-SSRS is to assess suicidal ideation and behavior. 4 constructs measured: severity of ideation, intensity of ideation, behavior, and lethality of actual suicide attempts. Yes/No data collected for 10 categories, composite endpoints based on the categories are followed over time to monitor safety. Composite endpoint of suicidal ideation (1-5), n and (%) are the number and % of who experience any of the five suicidal ideation events at least once after receiving the first dose of study medication. Composite endpoint of suicidal behavior (6-10), n and (%) are the number and percent of patients who experience any 1of 5 suicidal behavior events at least 1 after receiving the 5 dose of study medication. Composite endpoint of suicidal ideation or behavior (1-10), n and (%) are the number and % of patients who experience any 1 the 10 suicidal ideation or behavior events at least once after receiving the first dose of study medication.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) are included. All other data were not evaluable due to participants' discontinuation"}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Cognition, Using Montreal Cognitive Assessment (MoCA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '60', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Tominersen 120mg Q4W (Period 1)', 'description': 'Period 1 Tominersen 120mg Q4W Participants received open-label RO7234292 Q4W in this Period 1'}, {'id': 'OG001', 'title': 'Tominersen 120mg Q8W (Prior Q4w)', 'description': 'Participants received open-label RO7234292 Q8W after having received Q4W treatment previously'}, {'id': 'OG002', 'title': 'Tominersen 120mg Q8W (No Loading)', 'description': 'Participants received open-label RO7234292 Q8W without prior treatment with RO7234292'}, {'id': 'OG003', 'title': 'Tominersen 120mg Q8W (With Loading)', 'description': 'Participants received open-label RO7234292 Q8W with prior treatment with RO7234292 Q8W'}, {'id': 'OG004', 'title': 'Tominersen 120mg Q8W (Prior BP40410)', 'description': 'Participants received open-label RO7234292 Q8W with prior treatment with RO7234292 Q4W in study BP40410'}, {'id': 'OG005', 'title': 'Tominersen 120mg Q16W (Prior Q4W)', 'description': 'Participants received open-label RO7234292 Q16W after having received Q4W treatment previously'}, {'id': 'OG006', 'title': 'Tominersen 120mg Q16W (No Loading)', 'description': 'Participants received open-label RO7234292 Q16W without prior treatment with RO7234292'}, {'id': 'OG007', 'title': 'Tominersen 120mg Q16W (Prior BP40410)', 'description': 'Participants received open-label RO7234292 Q16W with prior treatment with RO7234292 Q4W in study BP40410'}], 'classes': [{'title': 'MOCA01-Total Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '58', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '24.50', 'spread': '3.98', 'groupId': 'OG000'}, {'value': '25.08', 'spread': '3.49', 'groupId': 'OG001'}, {'value': '24.92', 'spread': '3.47', 'groupId': 'OG002'}, {'value': '24.62', 'spread': '4.44', 'groupId': 'OG003'}, {'value': '25.33', 'spread': '1.53', 'groupId': 'OG004'}, {'value': '23.43', 'spread': '4.49', 'groupId': 'OG005'}, {'value': '24.03', 'spread': '3.88', 'groupId': 'OG006'}, {'value': '19.75', 'spread': '4.35', 'groupId': 'OG007'}]}]}, {'title': 'MOCA01-Total Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '53', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-4.00', 'spread': 'NA', 'comment': 'No data available in the range', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '2.19', 'groupId': 'OG001'}, {'value': '0.16', 'spread': '2.58', 'groupId': 'OG002'}, {'value': '0.19', 'spread': '2.56', 'groupId': 'OG003'}, {'value': '-1.00', 'spread': '1.00', 'groupId': 'OG004'}, {'value': '-0.57', 'spread': '2.01', 'groupId': 'OG005'}, {'value': '-0.17', 'spread': '2.79', 'groupId': 'OG006'}, {'value': '3.25', 'spread': '2.36', 'groupId': 'OG007'}]}]}, {'title': 'MOCA01-Total Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '3.00', 'spread': 'NA', 'comment': 'No data available in the range', 'groupId': 'OG000'}]}]}, {'title': 'MOCA01-Total Week 33', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '47', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '3.00', 'spread': 'NA', 'comment': 'No data available in the range', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '1.74', 'groupId': 'OG001'}, {'value': '0.28', 'spread': '2.61', 'groupId': 'OG002'}, {'value': '0.35', 'spread': '1.76', 'groupId': 'OG003'}, {'value': '0.67', 'spread': '2.08', 'groupId': 'OG004'}, {'value': '-0.90', 'spread': '2.76', 'groupId': 'OG005'}, {'value': '0.32', 'spread': '2.44', 'groupId': 'OG006'}, {'value': '2.25', 'spread': '2.22', 'groupId': 'OG007'}]}]}, {'title': 'MOCA01-Total Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '53', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0.33', 'spread': '2.33', 'groupId': 'OG001'}, {'value': '-0.39', 'spread': '2.83', 'groupId': 'OG002'}, {'value': '-0.08', 'spread': '2.26', 'groupId': 'OG003'}, {'value': '-0.67', 'spread': '3.06', 'groupId': 'OG004'}, {'value': '-0.40', 'spread': '2.68', 'groupId': 'OG005'}, {'value': '-0.13', 'spread': '2.53', 'groupId': 'OG006'}, {'value': '3.00', 'spread': '3.46', 'groupId': 'OG007'}]}]}, {'title': 'MOCA01-Total Week 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '48', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-0.09', 'spread': '2.09', 'groupId': 'OG001'}, {'value': '-0.08', 'spread': '2.56', 'groupId': 'OG002'}, {'value': '-0.08', 'spread': '1.91', 'groupId': 'OG003'}, {'value': '-5.00', 'spread': 'NA', 'comment': 'No data available in the range', 'groupId': 'OG004'}, {'value': '-0.43', 'spread': '2.86', 'groupId': 'OG005'}, {'value': '0.27', 'spread': '2.85', 'groupId': 'OG006'}, {'value': '0.50', 'spread': '3.54', 'groupId': 'OG007'}]}]}, {'title': 'MOCA01-Total Week 81', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '41', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0.59', 'spread': '1.30', 'groupId': 'OG001'}, {'value': '-0.38', 'spread': '3.31', 'groupId': 'OG002'}, {'value': '-0.09', 'spread': '1.95', 'groupId': 'OG003'}, {'value': '-2.00', 'spread': 'NA', 'comment': 'No data available in the range', 'groupId': 'OG004'}, {'value': '0.25', 'spread': '2.57', 'groupId': 'OG005'}, {'value': '-0.24', 'spread': '2.90', 'groupId': 'OG006'}, {'value': '0.50', 'spread': '3.54', 'groupId': 'OG007'}]}]}, {'title': 'MOCA01-Total Week 97', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-0.47', 'spread': '2.06', 'groupId': 'OG001'}, {'value': '-0.97', 'spread': '3.12', 'groupId': 'OG002'}, {'value': '0.45', 'spread': '2.20', 'groupId': 'OG003'}, {'value': '0.24', 'spread': '2.46', 'groupId': 'OG005'}, {'value': '-0.46', 'spread': '3.01', 'groupId': 'OG006'}]}]}, {'title': 'MOCA01-Total Week 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0.18', 'spread': '1.94', 'groupId': 'OG001'}, {'value': '-0.36', 'spread': '2.65', 'groupId': 'OG002'}, {'value': '0.10', 'spread': '2.62', 'groupId': 'OG003'}, {'value': '0.19', 'spread': '2.51', 'groupId': 'OG005'}, {'value': '0.36', 'spread': '3.01', 'groupId': 'OG006'}]}]}, {'title': 'MOCA01-Total Week 129', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-0.75', 'spread': '1.22', 'groupId': 'OG001'}, {'value': '-0.50', 'spread': '1.95', 'groupId': 'OG002'}, {'value': '-0.15', 'spread': '3.48', 'groupId': 'OG003'}, {'value': '-0.11', 'spread': '1.90', 'groupId': 'OG005'}, {'value': '2.20', 'spread': '3.19', 'groupId': 'OG006'}]}]}, {'title': 'MOCA01-Total Week 145', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0.33', 'spread': '1.53', 'groupId': 'OG001'}, {'value': '-4.83', 'spread': '5.91', 'groupId': 'OG003'}, {'value': '0.00', 'spread': 'NA', 'comment': 'No data available in the range', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Approximately 3 Years', 'description': 'MoCA contains a series of basic assessments, including attention and visuospatial tasks. The total score ranges from 0-30, where lower scores indicate greater impairment.\n\nMOCA01-Total scores are reported. The data presented are absolute scores for baseline and change from baseline for post-baseline assessments.\n\nAll Arms except Tominersen 120mg Q4W (Period 1) belong to the Milestone Period 2.', 'unitOfMeasure': 'Score of a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Data evaluable participants were reported, all other data are not available. Only those participants who contributed and whose data were analyzed for data are reported in the table.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tominersen 120mg Q4W', 'description': 'Participants received open-label RO7234292 Q4W in this Arm'}, {'id': 'FG001', 'title': 'Tominersen 120mg Q8W', 'description': 'Participants received open-label RO7234292 Q8W in this Arm'}, {'id': 'FG002', 'title': 'Tominersen 120mg Q16W', 'description': 'Participants received open-label RO7234292 Q16W in this Arm'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '138'}, {'groupId': 'FG002', 'numSubjects': '81'}]}, {'type': 'Period 1', 'comment': 'Period 1 has only 1 arm with 17 participants of which 15 were transferred to two Arms of Period 2 (8 and 7 participants, see below)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Period 2', 'comment': 'Period 2 has 2 arms: Tominersen 120mg Q8W (8 participants from Period 1 and 138 new participants enrolled) and Tominersen 120mg Q16W (7 participants from Period 1 and 81 new enrolled). There were no participants in arm Tominersen 120mg Q4W.', 'achievements': [{'comment': '8 and 7 Participants from Arm Tominersen 120mg Q4W (Period 1) joined newly enrolled 138 participants in this Arm of Period 2.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': '8 Participants from Arm Tominersen 120mg Q4W (Period 1) joined newly enrolled 138 participants in this Arm of Period 2.', 'groupId': 'FG001', 'numSubjects': '146'}, {'comment': '7 Participants from Arm Tominersen 120mg Q4W (Period 2) joined newly enrolled 81 participants in this Arm of Period 2', 'groupId': 'FG002', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'comment': 'None of the participants completed the study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '138'}, {'groupId': 'FG002', 'numSubjects': '81'}]}], 'dropWithdraws': [{'type': 'Participant declined follow-up visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': "Sponsor's decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '99'}, {'groupId': 'FG002', 'numSubjects': '61'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study consists of Period 1 and 2. All participants (17) in the Q4W arm stopped Q4W dosing (Period 1) and 15 participants continued into the two Arms of Period 2. Due to the statistical outputs available, Period 1 and 2 are reported as Milestones below. None of the participants completed the study.', 'preAssignmentDetails': 'Periods 1 and 2 are sequential. 15 from 17 participants from Period 1 Q4W were re-randomized to receive Tominersen 120 mg Q8W or Q16W in Period 2 randomly and blinded.\n\n.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '236', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Tominersen 120mg Q4W', 'description': 'Participants received open-label RO7234292 Q4W in this Arm'}, {'id': 'BG001', 'title': 'Tominersen 120mg Q8W', 'description': 'Participants received open-label RO7234292 Q8W in this Arm'}, {'id': 'BG002', 'title': 'Tominersen 120mg Q16W', 'description': 'Participants received open-label RO7234292 Q16W in this Arm'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '50.4', 'spread': '8.9', 'groupId': 'BG000'}, {'value': '50.4', 'spread': '8.9', 'groupId': 'BG003'}]}]}, {'title': 'Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '219', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '47.9', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '48.4', 'spread': '11.2', 'groupId': 'BG002'}, {'value': '48.2', 'spread': '10.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Population description: In the Milestone Period 2, 146 and 88 participants received 120 mg Tominersen Q8W and Q16W respectively, with 15 participants from the In Period 1 Milestone Arm. There is no data to report separately for Milestone Periods 1 and 2 as no such statistical analyses were performed without 15 participants from the Milestone Period 1 in Milestone Period 2.', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'After Period 1, 15 patients continued to Period 2 with re-randomization'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '219', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '111', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Population Description: In the Milestone Period 2, 146 and 88 participants received 120 mg Tominersen Q8W and Q16W respectively, with 15 participants from the In Period 1 Milestone Arm. There is no data to report separately for Milestone Periods 1 and 2 as no such statistical analyses were performed without 15 participants from the Milestone Period 1 in Milestone Period 2.', 'unitOfMeasure': 'Participants', 'populationDescription': 'After Period 1, 15 patients continued to Period 2 with re-randomization'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '219', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '199', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Population Description: In the Milestone Period 2, 146 and 88 participants received 120 mg Tominersen Q8W and Q16W respectively, with 15 participants from the In Period 1 Milestone Arm. There is no data to report separately for Milestone Periods 1 and 2 as no such statistical analyses were performed without 15 participants from the Milestone Period 1 in Milestone Period 2.', 'unitOfMeasure': 'Participants', 'populationDescription': 'After Period 1, 15 patients continued to Period 2 with re-randomization'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '219', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '208', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Population Description: In the Milestone Period 2, 146 and 88 participants received 120 mg Tominersen Q8W and Q16W respectively, with 15 participants from the In Period 1 Milestone Arm. There is no data to report separately for Milestone Periods 1 and 2 as no such statistical analyses were performed without 15 participants from the Milestone Period 1 in Milestone Period 2.', 'unitOfMeasure': 'Participants', 'populationDescription': 'After Period 1, 15 patients continued to Period 2 with re-randomization'}], 'populationDescription': 'In Period 1 Milestone, 17 participants received 120 mg Tominersen Q4W Arm.\n\nIn the Milestone Period 2, 138 and 81 participants received 120 mg Tominersen Q8W and Q16W respectively, with 15 participants from the In Period 1 Milestone Arm. 8 and 7 participants from Period 1 joined the two arms of Period 2. Period 2 did not have the arm Tominersen 120mg Q4W.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-02', 'size': 1385693, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-16T05:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-09', 'studyFirstSubmitDate': '2019-02-11', 'resultsFirstSubmitDate': '2023-03-16', 'studyFirstSubmitQcDate': '2019-02-14', 'lastUpdatePostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-09', 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Treatment Emergent Adverse Events', 'timeFrame': 'Up to Approximately 3 Years', 'description': 'The reported are the treatment-emergent AEs with an onset date up to 5 months after last study drug intake.'}, {'measure': 'Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Up to approximately 3 Years', 'description': 'C-SSRS is to assess suicidal ideation and behavior. 4 constructs measured: severity of ideation, intensity of ideation, behavior, and lethality of actual suicide attempts. Yes/No data collected for 10 categories, composite endpoints based on the categories are followed over time to monitor safety. Composite endpoint of suicidal ideation (1-5), n and (%) are the number and % of who experience any of the five suicidal ideation events at least once after receiving the first dose of study medication. Composite endpoint of suicidal behavior (6-10), n and (%) are the number and percent of patients who experience any 1of 5 suicidal behavior events at least 1 after receiving the 5 dose of study medication. Composite endpoint of suicidal ideation or behavior (1-10), n and (%) are the number and % of patients who experience any 1 the 10 suicidal ideation or behavior events at least once after receiving the first dose of study medication.'}, {'measure': 'Change From Baseline in Cognition, Using Montreal Cognitive Assessment (MoCA)', 'timeFrame': 'Up to Approximately 3 Years', 'description': 'MoCA contains a series of basic assessments, including attention and visuospatial tasks. The total score ranges from 0-30, where lower scores indicate greater impairment.\n\nMOCA01-Total scores are reported. The data presented are absolute scores for baseline and change from baseline for post-baseline assessments.\n\nAll Arms except Tominersen 120mg Q4W (Period 1) belong to the Milestone Period 2.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Huntington Disease']}, 'descriptionModule': {'briefSummary': "This study will evaluate the long-term safety and tolerability of RO7234292 (RG6042) in participants who have completed other F. Hoffmann-La Roche, Ltd.-sponsored and/or Genentech-sponsored studies in the Huntington's disease (HD) in the development program for RG6042.", 'detailedDescription': 'Entry into the study should occur at the time the participant completes participation in one of the preceding studies. Upon completion of the inclusion visit, eligible participants will receive either RO7234292 (RG6042) every 8 weeks (Q8W) or RO7234292 (RG6042) every 16 weeks (Q16W) by the bolus intrathecal injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Prior enrollment in a Roche-sponsored or Genentech-sponsored study in HD for the RO7234292 (RG6042) development program that made provision for entry into an OLE study\n* For women of childbearing potential: agreement to remain abstinent or use contraceptive measures\n* For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm\n* Patients who were screened and eligible for the placebo-controlled Phase III Study BN40423 but could not be randomized prior to the close of Study BN40423 enrollment due to challenges relating to the COVID-19 pandemic\n\nInclusion criteria of patients who were screened and eligible for the placebo-controlled Phase III Study BN40423 but could not be randomized prior to the close of Study BN40423 enrollment due to challenges relating to the COVID-19 pandemic:\n\n* Manifest HD diagnosis, defined as a DCL score of 4\n* Independence Scale (IS) score \\>=70\n* Genetically confirmed disease by direct DNA testing with a CAP score \\>400\n* Clinical assessment to ensure individual has intact functional independence at baseline to maintain self-care and core activities of daily living (ADLs).\n\nExclusion Criteria:\n\n* Withdrawal of consent from the preceding study\n* Permanent discontinuation of RO7234292 (RG6042) for any drug-related safety concern during the preceding study or meeting of any study treatment discontinuation criteria specified in the preceding study at the time of enrollment into this study\n* An ongoing, unresolved, clinically significant medical problem that in the judgment of the investigator would make it unsafe for the patient to participate in this study\n* Antiplatelet or anticoagulant therapy within 14 days prior to inclusion or anticipated use during the study, including, but not limited to, aspirin, clopidogrel, dipyridamole, warfarin, dabigatran, rivaroxaban, and apixaban\n* History of bleeding diathesis or coagulopathy\n* Platelet count less than the lower limit of normal\n* Concurrent participation in any therapeutic clinical trial\n* Study treatment (RO7234292/RG6042) is commercially marketed in the patient's country for the patient-specific disease and is accessible to the patient\n* Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study drug\n\nExclusion criteria of patients who were screened and eligible for the placebo-controlled Phase III Study BN40423 but could not be randomized prior to the close of Study BN40423 enrollment due to challenges relation to the COVID-19 pandemic:\n\n* Any serious medical condition or clinically significant laboratory, or vital sign abnormality or claustrophobia at screening that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study\n* Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study drug"}, 'identificationModule': {'nctId': 'NCT03842969', 'briefTitle': "An Open-Label Extension Study to Evaluate Long-Term Safety and Tolerability of RO7234292 (RG6042) in Huntington's Disease Participants Who Participated in Prior Roche and Genentech Sponsored Studies", 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': "An Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intrathecally Administered RO7234292 (RG6042) in Patients With Huntington's Disease", 'orgStudyIdInfo': {'id': 'BN40955'}, 'secondaryIdInfos': [{'id': '2018-003898-94', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RO7234292 (RG6042) Q8W', 'description': 'Participants who received open-label RO7234292 Q4W in a preceding study or who received RO7234292 Q4W in this study may be randomly allocated to receive RO7234292 Q8W. Participants who previously received open-label of RO7234292 Q8W in a preceding study or are currently receiving RO7234292 Q8W in this study will receive RO7234292 Q8W. Participants who previously received placebo, or did not previously receive treatment with RO7234292 or received short-term treatment with a treatment-free follow-up period may be randomly allocated to receive RO7234292 Q8W. Participants who previously received blinded placebo Q8W may receive RO7234292 Q8W. Participants who received blinded RO7234292 Q8W will receive open-label RO7234929 Q8W. Participants who received blinded placebo Q8W may receive RO7234292 Q8W. Participants who received blinded RO7234292 Q4W or blinded placebo Q4W may be randomly allocated to receive open-label of RO7234292 Q8W.', 'interventionNames': ['Drug: RO7234292 (RG6042)']}, {'type': 'EXPERIMENTAL', 'label': 'RO7234292 (RG6042) Q16W', 'description': 'Participants who previously received open-label RO7234292 Q4W in a preceding study or who received RO7234292 Q4W in this study may be randomly allocated to receive RO7234292 Q16W. Participants who previously received placebo in a preceding study or did not previously receive treatment with RO7234292 or received short-term treatment with a treatment-free follow-up period may be randomly allocated to receive RO7234292 Q16W. Participants who previously received blinded placebo Q8W will receive RO7234292 Q8W. Participants who previously received blinded RO7234292 Q16W will receive open-label RO7234292 Q16W. Participants who received blinded RO7234292 Q4W or blinded placebo Q4W may be randomly allocated to receive open-label of RO7234292 Q16W. 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