Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-03-02 @ 10:01 AM
Study NCT ID:
NCT03225833
Status:
TERMINATED
Last Update Posted:
2022-02-10
First Post:
2017-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Tolerability of WVE-120101 in Patients With Huntington's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@wavelifesci.com', 'phone': '855-215-4687', 'title': 'Medical Director', 'organization': 'Wave Life Sciences'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Day 1 to end of study (Day 196 [32 mg cohort] or Day 210 [all other cohorts])', 'eventGroups': [{'id': 'EG000', 'title': 'Pooled Placebo', 'description': 'Placebo: 0.9% Sodium Chloride', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 12, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'WVE-120101 (2 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 8, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'WVE-120101 (4 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 8, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'WVE-120101 (8 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'WVE-120101 (16 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'WVE-120101 (32 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 9, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRa 8.2'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.2'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.2'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.2'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.2'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.2'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.2'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.2'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.2'}, {'term': 'Administration site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.2'}, {'term': 'Administration site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.2'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.2'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.2'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.2'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.2'}, {'term': 'Puncture site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 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infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.2'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.2'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 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0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.2'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.2'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 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9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.2'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.2'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.2'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety: Number of Patients With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'Placebo: 0.9% Sodium Chloride'}, {'id': 'OG001', 'title': 'WVE-120101 (2 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG002', 'title': 'WVE-120101 (4 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG003', 'title': 'WVE-120101 (8 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG004', 'title': 'WVE-120101 (16 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG005', 'title': 'WVE-120101 (32 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])', 'description': 'All TEAEs reported or observed during the study, including TEAEs resulting from concurrent illnesses, reactions to concurrent medications, or progression of disease states', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Safety: Severity of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'Placebo: 0.9% Sodium Chloride'}, {'id': 'OG001', 'title': 'WVE-120101 (2 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG002', 'title': 'WVE-120101 (4 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG003', 'title': 'WVE-120101 (8 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG004', 'title': 'WVE-120101 (16 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG005', 'title': 'WVE-120101 (32 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])', 'description': 'Number of patients who experienced a severe treatment-emergent adverse event. Severity was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Safety: Number of Patients With Serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'Placebo: 0.9% Sodium Chloride'}, {'id': 'OG001', 'title': 'WVE-120101 (2 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG002', 'title': 'WVE-120101 (4 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG003', 'title': 'WVE-120101 (8 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG004', 'title': 'WVE-120101 (16 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG005', 'title': 'WVE-120101 (32 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])', 'description': 'A serious TEAE is defined as any event that results in death, is immediately life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect not present at Prescreening.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Safety and Tolerability: Number of Patients Who Withdraw Due to TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'Placebo: 0.9% Sodium Chloride'}, {'id': 'OG001', 'title': 'WVE-120101 (2 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG002', 'title': 'WVE-120101 (4 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG003', 'title': 'WVE-120101 (8 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG004', 'title': 'WVE-120101 (16 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG005', 'title': 'WVE-120101 (32 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Maximum Observed Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'WVE-120101 (2 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG001', 'title': 'WVE-120101 (4 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG002', 'title': 'WVE-120101 (8 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG003', 'title': 'WVE-120101 (16 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG004', 'title': 'WVE-120101 (32 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7.70', 'spread': '7.901', 'groupId': 'OG000'}, {'value': '23.54', 'spread': '18.139', 'groupId': 'OG001'}, {'value': '32.82', 'spread': '22.964', 'groupId': 'OG002'}, {'value': '184.48', 'spread': '209.470', 'groupId': 'OG003'}, {'value': '229.01', 'spread': '168.330', 'groupId': 'OG004'}]}]}, {'title': 'Day 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13.296', 'spread': '6.057', 'groupId': 'OG000'}, {'value': '14.27', 'spread': '12.574', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose.', 'description': 'Cmax of WVE-120101 in plasma', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population consists of all treated patients in the safety population with at least 1 post-dose plasma or CSF WVE-120101 concentration measurement. The number of overall participants analyzed represents the number with at least 1 postdose plasma or CSF measurement at Day 1. The overall number of patients was different for Day 112, and represents patients with at least 1 postdose plasma or CSF measurement at Day 112.'}, {'type': 'SECONDARY', 'title': 'PK: Time of Occurrence of Cmax (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'WVE-120101 (2 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG001', 'title': 'WVE-120101 (4 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG002', 'title': 'WVE-120101 (8 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG003', 'title': 'WVE-120101 (16 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG004', 'title': 'WVE-120101 (32 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.34', 'spread': '1.103', 'groupId': 'OG000'}, {'value': '1.58', 'spread': '1.081', 'groupId': 'OG001'}, {'value': '2.66', 'spread': '1.391', 'groupId': 'OG002'}, {'value': '2.71', 'spread': '3.068', 'groupId': 'OG003'}, {'value': '4.61', 'spread': '7.054', 'groupId': 'OG004'}]}]}, {'title': 'Day 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.99', 'spread': '0.934', 'groupId': 'OG000'}, {'value': '2.23', 'spread': '1.175', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose.', 'description': 'tmax of WVE-120101 in plasma', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population consists of all treated patients in the safety population with at least 1 post-dose plasma or CSF WVE-120101 concentration measurement. The number of overall participants analyzed represents the number with at least 1 postdose plasma or CSF measurement at Day 1. The overall number of patients was different for Day 112, and represents patients with at least 1 postdose plasma or CSF measurement at Day 112.'}, {'type': 'SECONDARY', 'title': 'PK: Area Under the Plasma Concentration-time Curve (AUClast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'WVE-120101 (2 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG001', 'title': 'WVE-120101 (4 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG002', 'title': 'WVE-120101 (8 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG003', 'title': 'WVE-120101 (16 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG004', 'title': 'WVE-120101 (32 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '35.20', 'spread': '16.037', 'groupId': 'OG000'}, {'value': '90.77', 'spread': '50.672', 'groupId': 'OG001'}, {'value': '255.14', 'spread': '98.342', 'groupId': 'OG002'}, {'value': '1133.74', 'spread': '551.997', 'groupId': 'OG003'}, {'value': '1968.31', 'spread': '1188.173', 'groupId': 'OG004'}]}]}, {'title': 'Day 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '36.19', 'spread': '20.135', 'groupId': 'OG000'}, {'value': '49.54', 'spread': '34.735', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose.', 'description': 'AUClast from time 0 to the last quantifiable concentration of WVE-120101 in plasma', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population consists of all treated patients in the safety population with at least 1 post-dose plasma or CSF WVE-120101 concentration measurement. The number of overall participants analyzed represents the number with at least 1 postdose plasma or CSF measurement at Day 1. The overall number of patients was different for Day 112, and represents patients with at least 1 postdose plasma or CSF measurement at Day 112.'}, {'type': 'SECONDARY', 'title': 'PK: Terminal Elimination Half Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'WVE-120101 (2 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG001', 'title': 'WVE-120101 (4 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG002', 'title': 'WVE-120101 (8 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG003', 'title': 'WVE-120101 (16 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG004', 'title': 'WVE-120101 (32 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}], 'classes': [{'categories': [{'measurements': [{'value': '8.12', 'groupId': 'OG002', 'lowerLimit': '7.1', 'upperLimit': '40.0'}, {'value': '12.30', 'groupId': 'OG003', 'lowerLimit': '6.9', 'upperLimit': '25.5'}, {'value': '14.38', 'groupId': 'OG004', 'lowerLimit': '5.5', 'upperLimit': '46.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose.', 'description': 'Terminal elimination half life of WVE-120101 in plasma (t1/2)', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The t1/2 value was calculated using data from patients who had at least 3 postdose concentration values in the terminal phase. No patients had sufficient postdose samples at Day 112 to calculate t1/2 values.'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'Placebo: 0.9% Sodium Chloride'}, {'id': 'OG001', 'title': 'WVE-120101 (2 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG002', 'title': 'WVE-120101 (4 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG003', 'title': 'WVE-120101 (8 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG004', 'title': 'WVE-120101 (16 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG005', 'title': 'WVE-120101 (32 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.62', 'groupId': 'OG000', 'lowerLimit': '-16.76', 'upperLimit': '7.73'}, {'value': '-5.20', 'groupId': 'OG001', 'lowerLimit': '-10.94', 'upperLimit': '0.15'}, {'value': '-12.33', 'groupId': 'OG002', 'lowerLimit': '-19.81', 'upperLimit': '9.63'}, {'value': '-8.58', 'groupId': 'OG003', 'lowerLimit': '-11.92', 'upperLimit': '-1.79'}, {'value': '-11.73', 'groupId': 'OG004', 'lowerLimit': '-20.44', 'upperLimit': '3.37'}, {'value': '-9.13', 'groupId': 'OG005', 'lowerLimit': '-37.51', 'upperLimit': '15.29'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 to last observation - up to Day 140 (32 mg cohort) or Day 196 (all other cohorts)', 'description': 'Percentage change from baseline in concentration of mutant huntingtin (mHTT) protein in CSF', 'unitOfMeasure': 'Percent change from baseline', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Effects: Total Functional Capacity (TFC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'Placebo: 0.9% Sodium Chloride'}, {'id': 'OG001', 'title': 'WVE-120101 (2 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG002', 'title': 'WVE-120101 (4 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG003', 'title': 'WVE-120101 (8 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG004', 'title': 'WVE-120101 (16 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'OG005', 'title': 'WVE-120101 (32 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-9.09', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-4.17', 'upperLimit': '9.09'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '-7.69', 'upperLimit': '11.11'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '-20.00', 'upperLimit': '0.00'}, {'value': '4.17', 'groupId': 'OG004', 'lowerLimit': '-3.85', 'upperLimit': '10.42'}, {'value': '0.00', 'groupId': 'OG005', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 to last observation - up to Day 140 (32 mg cohort) or Day 196 (all other cohorts)', 'description': "Percentage change from baseline to the last measured time point in the Total Functional Capacity score, administered as part of the Unified Huntington's Disease Rating Scale (UHDRS). Total Functional Capacity is scored 13 (normal) to 0 (severe disability).", 'unitOfMeasure': '% Change from Baseline', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pooled Placebo', 'description': 'Placebo: 0.9% Sodium Chloride'}, {'id': 'FG001', 'title': 'WVE-120101 (2 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'FG002', 'title': 'WVE-120101 (4 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'FG003', 'title': 'WVE-120101 (8 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'FG004', 'title': 'WVE-120101 (16 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'FG005', 'title': 'WVE-120101 (32 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '10'}]}, {'type': 'Single Dose Period Only', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'Multiple Dose Period Only', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Single Dose and Multiple Dose Periods', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Termination of Study by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'Sponsor Decision', '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'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '61', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Pooled Placebo', 'description': 'Placebo: 0.9% Sodium Chloride'}, {'id': 'BG001', 'title': 'WVE-120101 (2 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'BG002', 'title': 'WVE-120101 (4 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'BG003', 'title': 'WVE-120101 (8 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'BG004', 'title': 'WVE-120101 (16 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'BG005', 'title': 'WVE-120101 (32 mg)', 'description': 'WVE-120101: WVE-120101 is a stereopure antisense oligonucleotide (ASO)'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '60', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '29', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '61', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', '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': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'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': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '61', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Time since initial diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '7', 'spread': '6.93', 'groupId': 'BG000'}, {'value': '4.9', 'spread': '4.28', 'groupId': 'BG001'}, {'value': '3.4', 'spread': '6.37', 'groupId': 'BG002'}, {'value': '3.2', 'spread': '3.03', 'groupId': 'BG003'}, {'value': '6.6', 'spread': '6.09', 'groupId': 'BG004'}, {'value': '8.7', 'spread': '7.26', 'groupId': 'BG005'}, {'value': '5.4', 'spread': '5.80', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age at Disease Onset', 'classes': [{'categories': [{'measurements': [{'value': '40.75', 'spread': '11.079', 'groupId': 'BG000'}, {'value': '37.33', 'spread': '7.826', 'groupId': 'BG001'}, {'value': '42.89', 'spread': '9.280', 'groupId': 'BG002'}, {'value': '46.11', 'spread': '6.254', 'groupId': 'BG003'}, {'value': '44.88', 'spread': '12.495', 'groupId': 'BG004'}, {'value': '44.60', 'spread': '10.865', 'groupId': 'BG005'}, {'value': '43.16', 'spread': '9.625', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diagnosis Stage', 'classes': [{'categories': [{'title': 'Stage 1', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '33', 'groupId': 'BG006'}]}, {'title': 'Stage 2', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '28', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Stage of disease, as defined by United Huntington's Disease Rating Scale, Total Functional Capacity Score. Stage 1 (least severe) = scores of 11 to 13. Stage 2 = scores of 7 to 10. Stages go up to Stage 5 = score of 0.", 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-21', 'size': 1154013, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-12-13T15:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'whyStopped': 'Lack of Efficacy', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-09', 'studyFirstSubmitDate': '2017-07-17', 'resultsFirstSubmitDate': '2021-12-17', 'studyFirstSubmitQcDate': '2017-07-20', 'lastUpdatePostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-09', 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety: Number of Patients With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])', 'description': 'All TEAEs reported or observed during the study, including TEAEs resulting from concurrent illnesses, reactions to concurrent medications, or progression of disease states'}, {'measure': 'Safety: Severity of Adverse Events', 'timeFrame': 'Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])', 'description': 'Number of patients who experienced a severe treatment-emergent adverse event. Severity was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0'}, {'measure': 'Safety: Number of Patients With Serious TEAEs', 'timeFrame': 'Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])', 'description': 'A serious TEAE is defined as any event that results in death, is immediately life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect not present at Prescreening.'}, {'measure': 'Safety and Tolerability: Number of Patients Who Withdraw Due to TEAEs', 'timeFrame': 'Day 1 to end of study (up to Day 182 [32 mg cohort]/ Day 210 [all other cohorts])'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Maximum Observed Concentration (Cmax)', 'timeFrame': 'Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose.', 'description': 'Cmax of WVE-120101 in plasma'}, {'measure': 'PK: Time of Occurrence of Cmax (Tmax)', 'timeFrame': 'Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose.', 'description': 'tmax of WVE-120101 in plasma'}, {'measure': 'PK: Area Under the Plasma Concentration-time Curve (AUClast)', 'timeFrame': 'Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose.', 'description': 'AUClast from time 0 to the last quantifiable concentration of WVE-120101 in plasma'}, {'measure': 'PK: Terminal Elimination Half Life', 'timeFrame': 'Patients participating in Period 1 (SAD) had PK samples collected on Day 1 predose through 24-48 hours postdose. Patients participating in Period 2 (MAD) had PK samples collected predose on Day 112 and through 4 hours postdose.', 'description': 'Terminal elimination half life of WVE-120101 in plasma (t1/2)'}, {'measure': 'Pharmacodynamics', 'timeFrame': 'Day 1 to last observation - up to Day 140 (32 mg cohort) or Day 196 (all other cohorts)', 'description': 'Percentage change from baseline in concentration of mutant huntingtin (mHTT) protein in CSF'}, {'measure': 'Clinical Effects: Total Functional Capacity (TFC)', 'timeFrame': 'Day 1 to last observation - up to Day 140 (32 mg cohort) or Day 196 (all other cohorts)', 'description': "Percentage change from baseline to the last measured time point in the Total Functional Capacity score, administered as part of the Unified Huntington's Disease Rating Scale (UHDRS). Total Functional Capacity is scored 13 (normal) to 0 (severe disability)."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Huntington's Disease"]}, 'referencesModule': {'references': [{'pmid': '32250312', 'type': 'DERIVED', 'citation': "Rodrigues FB, Wild EJ. Huntington's Disease Clinical Trials Corner: April 2020. J Huntingtons Dis. 2020;9(2):185-197. doi: 10.3233/JHD-200002."}, {'pmid': '29480210', 'type': 'DERIVED', 'citation': "Rodrigues FB, Wild EJ. Huntington's Disease Clinical Trials Corner: February 2018. J Huntingtons Dis. 2018;7(1):89-98. doi: 10.3233/JHD-189001."}]}, 'descriptionModule': {'briefSummary': "PRECISION-HD1 is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of WVE-120101 in adult patients with early manifest Huntington's disease (HD) who carry a targeted single nucleotide polymorphism (SNP) rs362307 (SNP1)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Prescreened with targeted SNP on the same allele as the pathogenic CAG expansion\n* Ambulatory, male or female patients aged ≥25 - ≤65 years\n* Clinical diagnostic motor features of HD, defined as Unified Huntington's Disease Rating Scale (UHDRS) Diagnostic Confidence Score = 4\n* Early manifest HD, Stage I or Stage II based on UHDRS Total Functional Capacity Scores ≥7 and ≤13\n\nKey Exclusion Criteria:\n\n* Malignancy or received treatment for malignancy, other than treated basal cell or squamous cell carcinoma of the skin, within the previous 5 years.\n* Received investigational drug or implantable device in prior 3 months or investigational oligonucleotide in prior 6 months or 5 half-lives of the oligonucleotide, whichever is longer\n* Clinically significant medical condition, unstable psychiatric symptoms, substance abuse, or pregnancy\n* Inability to undergo brain MRI\n* Bone, spine, bleeding, or other disorder that exposes the patient to risk of injury or unsuccessful lumbar puncture"}, 'identificationModule': {'nctId': 'NCT03225833', 'acronym': 'PRECISION-HD1', 'briefTitle': "Safety and Tolerability of WVE-120101 in Patients With Huntington's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Wave Life Sciences Ltd.'}, 'officialTitle': "A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120101 Administered Intrathecally in Patients With Huntington's Disease", 'orgStudyIdInfo': {'id': 'WVE-HDSNP1-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WVE-120101 (Dose A) or placebo', 'interventionNames': ['Drug: WVE-120101', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'WVE-120101 (Dose B) or placebo', 'interventionNames': ['Drug: WVE-120101', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'WVE-120101 (Dose C) or placebo', 'interventionNames': ['Drug: WVE-120101', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'WVE-120101 (Dose D) or placebo', 'interventionNames': ['Drug: WVE-120101', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'WVE-120101 (Dose E) or placebo', 'interventionNames': ['Drug: WVE-120101', 'Drug: Placebo']}], 'interventions': [{'name': 'WVE-120101', 'type': 'DRUG', 'description': 'WVE-120101 is a stereopure antisense oligonucleotide (ASO)', 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Disorders', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2X0A9', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Center Hospitalier de l'Universite de Montreal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus Universitets Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital and University of Southern Denmark', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Hospital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '75646', 'city': 'Paris', 'country': 'France', 'facility': 'Institut du Cerveau et de la Moelle Epinière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'George-Huntington-Institut GmbH', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '80-462', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Szpital Sw. Wojciecha', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '02-957', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Instytut Psychiatrii i Neurologii', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': 'EX2 5DW', 'city': 'Exeter', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'Royal Devon and Exeter Hospital NHS Trust', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'zip': 'G12 0XH', 'city': 'Glasgow', 'state': 'Glasgow City', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth University Hospital - PPDS', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'L7 8XP', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Royal Liverpool University Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}], 'overallOfficials': [{'name': 'Medical Director, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wave Life Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wave Life Sciences Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}