Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
Study NCT ID:
NCT04000594
Status:
COMPLETED
Last Update Posted:
2024-10-03
First Post:
2019-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Investigate the Pharmacokinetics and Pharmacodynamics of RO7234292 (RG6042) in CSF and Plasma, and Safety and Tolerability Following Intrathecal Administration in Patients With Huntington's Disease
Sponsor:
Organization:
Raw JSON
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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': 'The 2nd dose (last dose) of study drug on Day 29 and the last follow-up visit was 6 months after the last dose.', 'eventGroups': [{'id': 'EG000', 'title': '30 MG RG6042', 'description': 'Participants received dose level 1 of 30 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '60 MG RG6042', 'description': 'Participants will receive dose level 2 of 60 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': '120 MG RG6042', 'description': 'Participants will receive dose level 3 of 120 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA v 25.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA v 25.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA v 25.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MeDRA v 25.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 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'spread': '20000', 'groupId': 'OG002'}]}]}, {'title': 'Day 3 48 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '888', 'spread': '1510', 'groupId': 'OG000'}, {'value': '4540', 'spread': '3510', 'groupId': 'OG001'}, {'value': '6880', 'spread': '4830', 'groupId': 'OG002'}]}]}, {'title': 'Day 4 72 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'insufficient number of patients with available measures', 'groupId': 'OG001'}, {'value': '1270', 'spread': '1070', 'groupId': 'OG002'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.08', 'spread': '0.773', 'groupId': 'OG000'}, {'value': '1.51', 'spread': '0.757', 'groupId': 'OG001'}, {'value': '2.64', 'spread': '0.572', 'groupId': 'OG002'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.81', 'spread': '0.906', 'groupId': 'OG000'}, {'value': '3.97', 'spread': '1.85', 'groupId': 'OG001'}, {'value': '6.79', 'spread': '1.15', 'groupId': 'OG002'}]}]}, {'title': 'Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.08', 'spread': '0.459', 'groupId': 'OG000'}, {'value': '1.78', 'spread': '0.0919', 'groupId': 'OG001'}, {'value': '2.92', 'spread': '0.570', 'groupId': 'OG002'}]}]}, {'title': 'Day 127', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.329', 'spread': '0.129', 'groupId': 'OG000'}, {'value': '0.416', 'spread': '0.0361', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'insufficient number of patients with available measures', 'groupId': 'OG002'}]}]}, {'title': 'Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'insufficient number of patients with available measures', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'insufficient number of patients with available measures', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, 2, 3, 4, 29, 43, 71, 127, and follow-up visit (6 months after last study drug administration)', 'description': 'NA represents: insufficient number of participants with events.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population'}, {'type': 'PRIMARY', 'title': 'Concentrations of RO7234292 in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Level 1 of RO7234292 (RG6042)', 'description': 'Participants received dose level 1 of 30 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.'}, {'id': 'OG001', 'title': 'Dose Level 2 of RO7234292 (RG6042)', 'description': 'Participants received dose level 2 of 60 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.'}, {'id': 'OG002', 'title': 'Dose Level 3 of RO7234292 (RG6042)', 'description': 'Participants received dose level 3 of 120 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.'}], 'classes': [{'title': 'Day 1 1 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '209', 'spread': '173', 'groupId': 'OG000'}, {'value': '709', 'spread': '765', 'groupId': 'OG001'}, {'value': '941', 'spread': '625', 'groupId': 'OG002'}]}]}, {'title': 'Day 2 24 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30.5', 'spread': '31.1', 'groupId': 'OG000'}, {'value': '709', 'spread': '765', 'groupId': 'OG001'}, {'value': '104', 'spread': '84.6', 'groupId': 'OG002'}]}]}, {'title': 'Day 3 48 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.66', 'spread': '4.05', 'groupId': 'OG000'}, {'value': '5.87', 'spread': '5.36', 'groupId': 'OG001'}, {'value': '12.8', 'spread': '5.73', 'groupId': 'OG002'}]}]}, {'title': 'Day 4 72 hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.480', 'spread': '0.192', 'groupId': 'OG000'}, {'value': '1.76', 'spread': '1.25', 'groupId': 'OG001'}, {'value': '4.20', 'spread': '2.11', 'groupId': 'OG002'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'insufficient number of patients with available measures', 'groupId': 'OG000'}, {'value': '0.119', 'spread': '0.0273', 'groupId': 'OG001'}, {'value': '0.316', 'spread': '0.114', 'groupId': 'OG002'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.142', 'spread': '0.143', 'groupId': 'OG000'}, {'value': '0.135', 'spread': '0.132', 'groupId': 'OG001'}, {'value': '0.292', 'spread': '0.0887', 'groupId': 'OG002'}]}]}, {'title': 'Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '46.4', 'spread': '27.1', 'groupId': 'OG000'}, {'value': '103', 'spread': '52.0', 'groupId': 'OG001'}, {'value': '317', 'spread': '57.6', 'groupId': 'OG002'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.249', 'spread': '0.140', 'groupId': 'OG000'}, {'value': '0.356', 'spread': '0.195', 'groupId': 'OG001'}, {'value': '0.983', 'spread': '0.401', 'groupId': 'OG002'}]}]}, {'title': 'Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'insufficient number of patients with available measures', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'insufficient number of patients with available measures', 'groupId': 'OG001'}, {'value': '0.983', 'spread': '0.401', 'groupId': 'OG002'}]}]}, {'title': 'Day 127', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'insufficient number of patients with available measures', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, 2, 3, 4, 5, 28, 29, 30, 43, 71, 127, and follow-up visit (6 months after last study drug administration)', 'description': 'NA represents:insufficient number of participants with events', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population'}, {'type': 'PRIMARY', 'title': 'mHTT (Mutant Huntingtin) Concentration in CSF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Level 1 of RO7234292 (RG6042)', 'description': 'Participants received dose level 1 of 30 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.'}, {'id': 'OG001', 'title': 'Dose Level 2 of RO7234292 (RG6042)', 'description': 'Participants received dose level 2 of 60 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.'}, {'id': 'OG002', 'title': 'Dose Level 3 of RO7234292 (RG6042)', 'description': 'Participants received dose level 3 of 120 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.'}], 'classes': [{'title': 'Day 1 4H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '177.78', 'spread': '92.81', 'groupId': 'OG000'}, {'value': '130.35', 'spread': '40.16', 'groupId': 'OG001'}, {'value': '99.02', 'spread': '50.65', 'groupId': 'OG002'}]}]}, {'title': 'Day 2 24H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '204.39', 'spread': '180.26', 'groupId': 'OG000'}, {'value': '81.74', 'spread': '22.38', 'groupId': 'OG001'}, {'value': '127.39', 'spread': '42.40', 'groupId': 'OG002'}]}]}, {'title': 'Day 3 48H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '325.18', 'spread': '215.71', 'groupId': 'OG000'}, {'value': '190.85', 'spread': '161.19', 'groupId': 'OG001'}, {'value': '176.59', 'spread': '125.52', 'groupId': 'OG002'}]}]}, {'title': 'Day 29 Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '107.46', 'spread': '85.36', 'groupId': 'OG000'}, {'value': '91.53', 'spread': '20.65', 'groupId': 'OG001'}, {'value': '55.62', 'spread': '16.70', 'groupId': 'OG002'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '83.75', 'spread': '41.84', 'groupId': 'OG000'}, {'value': '66.07', 'spread': '1.08', 'groupId': 'OG001'}, {'value': '68.92', 'spread': '21.89', 'groupId': 'OG002'}]}]}, {'title': 'Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '138.25', 'spread': '127.63', 'groupId': 'OG000'}, {'value': '74.86', 'spread': '14.38', 'groupId': 'OG001'}, {'value': '49.24', 'spread': '12.50', 'groupId': 'OG002'}]}]}, {'title': 'Day 127', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '127.80', 'spread': '112.79', 'groupId': 'OG000'}, {'value': '81.05', 'spread': '21.84', 'groupId': 'OG001'}, {'value': '41.55', 'spread': '10.96', 'groupId': 'OG002'}]}]}, {'title': 'Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '132.13', 'spread': '115.59', 'groupId': 'OG000'}, {'value': '68.77', 'spread': '24.49', 'groupId': 'OG001'}, {'value': '61.55', 'spread': '8.84', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 2, 3, 29, 43, 71, 127 and follow-up visit (6 months after last study drug administration)', 'description': 'CSF Mutant Huntingtin Protein (fmol/L) values at time point visits are reported.', 'unitOfMeasure': 'fmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Level 1 of RO7234292 (RG6042)', 'description': 'Participants received dose level 1 of 30 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.'}, {'id': 'OG001', 'title': 'Dose Level 2 of RO7234292 (RG6042)', 'description': 'Participants received dose level 2 of 60 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.'}, {'id': 'OG002', 'title': 'Dose Level 3 of RO7234292 (RG6042)', 'description': 'Participants received dose level 3 of 120 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.'}], 'classes': [{'title': 'Any Adverse Events Level 1', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}]}]}, {'title': 'Any Adverse Events Level 2', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}]}]}, {'title': 'Any Adverse Events Level 3', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}]}]}, {'title': 'Injury, poisoning and procedural complications Level 1', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}]}, {'title': 'Injury, poisoning and procedural complications Level 2', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Injury, poisoning and procedural complications Level 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Musculoskeletal and connective tissue disorders Level 1', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}]}, {'title': 'Musculoskeletal and connective tissue disorders Level 2', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Musculoskeletal and connective tissue disorders Level 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Nervous system disorders Level 1', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}]}, {'title': 'Nervous system disorders Level 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Nervous system disorders Level 3', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'General disorders and administration site conditions Level 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'General disorders and administration site conditions Level 2', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'General disorders and administration site conditions Level 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Infections and infestations Level 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Infections and infestations Level 2', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Infections and infestations Level 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Gastrointestinal disorders Level 1', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}]}, {'title': 'Gastrointestinal disorders Level 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Gastrointestinal disorders Level 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Ear and labyrinth disorders Level 1', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Ear and labyrinth disorders Level 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Ear and labyrinth disorders Level 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Investigations Level 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Investigations Level 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Investigations Level 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Metabolism and nutrition disorders Leve 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Metabolism and nutrition disorders Leve 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Metabolism and nutrition disorders Leve 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Psychiatric disorders Level 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Psychiatric disorders Level 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Psychiatric disorders Level 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Reproductive system and breast disorders Level 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Reproductive system and breast disorders Level 2', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Reproductive system and breast disorders Level 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory, thoracic and mediastinal disorders Level 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory, thoracic and mediastinal disorders Level 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory, thoracic and mediastinal disorders Level 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Skin and subcutaneous tissue disorders Level 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Skin and subcutaneous tissue disorders Level 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Skin and subcutaneous tissue disorders Level 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months', 'description': 'Severity levels levels: 1 = mild; 2 = moderate; 3 = severe used according to NCI-CTCAE grading system.\n\nPercentage of participants with 1-3 levels of severities are reported.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Level 1 of RO7234292 (RG6042)', 'description': 'Participants received dose level 1 of 30 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.'}, {'id': 'OG001', 'title': 'Dose Level 2 of RO7234292 (RG6042)', 'description': 'Participants received dose level 2 of 60 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.'}, {'id': 'OG002', 'title': 'Dose Level 3 of RO7234292 (RG6042)', 'description': 'Participants received dose level 3 of 120 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.'}], 'classes': [{'title': 'Suicidal Ideation (score 1-5) -Wish to Be Dead', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Suicidal Ideation (score 1-5) -Non-specific Active Suicidal Thoughts', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-Active Suicidal Ideation with Any Suicidal Ideation (score 1-5) -Methods (Not Plan) without Intent', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Suicidal Ideation (score 1-5) -Intent to Act, without Plan Active Suicidal Ideation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Suicidal Ideation (score 1-5) -Active Suicidal Ideation with Specific Plan and Intent', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Suicidal Behavior (6-10) -Preparatory Acts or Behavior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Suicidal Behavior (6-10) -Aborted Attempt', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Suicidal Behavior (6-10) -Interrupted Attempt', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Suicidal Behavior (6-10) -Non-fatal Suicide Attempt', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Suicidal Behavior (6-10) -Completed Suicide', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Suicidal Behavior (6-10) -Self-injurious Behavior without Suicidal Intent', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Screening Day Up To Follow-up Visit (6 months after the last Dosing Day-Day 127)', 'description': 'The Columbia-Suicide Severity Rating Scale (C-SSRS) is a structured tool to assess suicidal ideation and behavior.\n\nFour constructs are measured: severity of ideation, intensity of ideation, behavior, and lethality of actual suicide attempts. Binary (yes/no) data are collected for 10 categories, and composite endpoints based on the categories are followed over time to monitor patient safety. Scores 1-10 is used, 1 being less and to 10 being severity increasing.\n\nOnly one time frame was used per score category: from screening to follow-up visit.', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Incidence of Anti-Drug Antibodies (ADAs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Level 1 of RO7234292 (RG6042)', 'description': 'Participants received dose level 1 of 30 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.'}, {'id': 'OG001', 'title': 'Dose Level 2 of RO7234292 (RG6042)', 'description': 'Participants received dose level 2 of 60 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.'}, {'id': 'OG002', 'title': 'Dose Level 3 of RO7234292 (RG6042)', 'description': 'Participants received dose level 3 of 120 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.'}], 'classes': [{'title': 'Baseline Day 1 Total Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}]}, {'title': 'Day 28 Total Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}]}, {'title': 'Follow-up Total Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, Day 28, and follow-up visit (6 months after last study drug administration)', 'description': 'Percentage of participants who have negative or positive anti-drug antibody affects are reported.', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Titer and Antibody Subtype, Determined if ADAs Are Identified', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Level 1 of RO7234292 (RG6042)', 'description': 'Participants received dose level 1 of 30 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.'}, {'id': 'OG001', 'title': 'Dose Level 2 of RO7234292 (RG6042)', 'description': 'Participants received dose level 2 of 60 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.'}, {'id': 'OG002', 'title': 'Dose Level 3 of RO7234292 (RG6042)', 'description': 'Participants received dose level 3 of 120 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.'}], 'timeFrame': 'Day 1, Day 28, and follow-up visit (6 months after last study drug administration)', 'description': 'The data cannot be reported and the outcome measure is not applicable as no ADA sample was positive. As no ADA, titer and subtype could not be identified', 'reportingStatus': 'POSTED', 'populationDescription': 'No data evaluable participants'}, {'type': 'SECONDARY', 'title': 'Amount of RO7234292 in Urine Ae (Micrograms)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Level 1 of RO7234292 (RG6042)', 'description': 'Participants received dose level 1 of 30 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.'}, {'id': 'OG001', 'title': 'Dose Level 2 of RO7234292 (RG6042)', 'description': 'Participants received dose level 2 of 60 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.'}, {'id': 'OG002', 'title': 'Dose Level 3 of RO7234292 (RG6042)', 'description': 'Participants received dose level 3 of 120 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.'}], 'classes': [{'categories': [{'measurements': [{'value': '236.0', 'spread': '78.0', 'groupId': 'OG000'}, {'value': '207.0', 'spread': '131.0', 'groupId': 'OG001'}, {'value': '1650.0', 'spread': '53.0', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Up to 72 hours', 'unitOfMeasure': 'micrograms', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dose Level 1 of RO7234292 (RG6042)', 'description': 'Participants received dose level 1 of 30 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.'}, {'id': 'FG001', 'title': 'Dose Level 2 of RO7234292 (RG6042)', 'description': 'Participants received dose level 2 of 60 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.'}, {'id': 'FG002', 'title': 'Dose Level 3 of RO7234292 (RG6042)', 'description': 'Participants received dose level 3 of 120 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Dose Level 1 of RO7234292 (RG6042)', 'description': 'Participants received dose level 1 of 30 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.'}, {'id': 'BG001', 'title': 'Dose Level 2 of RO7234292 (RG6042)', 'description': 'Participants received dose level 2 of 60 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.'}, {'id': 'BG002', 'title': 'Dose Level 3 of RO7234292 (RG6042)', 'description': 'Participants received dose level 3 of 120 mg RO7234292 (RG6042) intrathecally on Day 1 and Day 29.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.3', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '45.8', 'spread': '10.9', 'groupId': 'BG001'}, {'value': '53.8', 'spread': '6.9', 'groupId': 'BG002'}, {'value': '47.3', 'spread': '10.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], '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'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', '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', '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'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', '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': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-24', 'size': 1455528, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-01-13T04:58', 'hasProtocol': True}, {'date': '2020-06-15', 'size': 1378860, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-01-13T04:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-18', 'studyFirstSubmitDate': '2019-06-26', 'resultsFirstSubmitDate': '2023-01-13', 'studyFirstSubmitQcDate': '2019-06-26', 'lastUpdatePostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-18', 'studyFirstPostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentrations of RO7234292 in CSF (Cerebrospinal Fluid)', 'timeFrame': 'Day 1, 2, 3, 4, 29, 43, 71, 127, and follow-up visit (6 months after last study drug administration)', 'description': 'NA represents: insufficient number of participants with events.'}, {'measure': 'Concentrations of RO7234292 in Plasma', 'timeFrame': 'Day 1, 2, 3, 4, 5, 28, 29, 30, 43, 71, 127, and follow-up visit (6 months after last study drug administration)', 'description': 'NA represents:insufficient number of participants with events'}, {'measure': 'mHTT (Mutant Huntingtin) Concentration in CSF', 'timeFrame': 'Days 1, 2, 3, 29, 43, 71, 127 and follow-up visit (6 months after last study drug administration)', 'description': 'CSF Mutant Huntingtin Protein (fmol/L) values at time point visits are reported.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Adverse Events According to NCI-CTCAE Grading System', 'timeFrame': 'Up to 6 months', 'description': 'Severity levels levels: 1 = mild; 2 = moderate; 3 = severe used according to NCI-CTCAE grading system.\n\nPercentage of participants with 1-3 levels of severities are reported.'}, {'measure': 'Percentage of Participants With Suicidal Ideation or Behavior, as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score', 'timeFrame': 'From Screening Day Up To Follow-up Visit (6 months after the last Dosing Day-Day 127)', 'description': 'The Columbia-Suicide Severity Rating Scale (C-SSRS) is a structured tool to assess suicidal ideation and behavior.\n\nFour constructs are measured: severity of ideation, intensity of ideation, behavior, and lethality of actual suicide attempts. Binary (yes/no) data are collected for 10 categories, and composite endpoints based on the categories are followed over time to monitor patient safety. Scores 1-10 is used, 1 being less and to 10 being severity increasing.\n\nOnly one time frame was used per score category: from screening to follow-up visit.'}, {'measure': 'Incidence of Anti-Drug Antibodies (ADAs)', 'timeFrame': 'Day 1, Day 28, and follow-up visit (6 months after last study drug administration)', 'description': 'Percentage of participants who have negative or positive anti-drug antibody affects are reported.'}, {'measure': 'Titer and Antibody Subtype, Determined if ADAs Are Identified', 'timeFrame': 'Day 1, Day 28, and follow-up visit (6 months after last study drug administration)', 'description': 'The data cannot be reported and the outcome measure is not applicable as no ADA sample was positive. As no ADA, titer and subtype could not be identified'}, {'measure': 'Amount of RO7234292 in Urine Ae (Micrograms)', 'timeFrame': 'Up to 72 hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Huntingtons Disease']}, 'descriptionModule': {'briefSummary': "Study BP40410 is an open-label, adaptive multiple-dose clinical study designed to characterize the PK of RO7234292 (RG6042) in plasma and CSF as well as the acute time course and recovery profile of CSF mHTT lowering in response to RO7234292 (RG6042) treatment after intrathecal (IT) administration of RO7234292 (RG6042) to patients with manifest Hungtington's disease (HD)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Manifest HD diagnosis\n* Independence Scale score of \\>=70.\n* Genetically confirmed disease by direct deoxyribonucleic acid testing with a cytosine, adenine, and guanine base sequence found in DNA which is translated into glutamine (CAG) age product (CAP) score \\> 400.\n* Ability to read the words "red," "blue," and "green" in the patient\'s native language.\n* Ability to walk unassisted without a cane or walker and move about without a wheelchair on a daily basis as reviewed at screening and baseline visit.\n* Ability to undergo and tolerate MRI scans.\n\nExclusion Criteria:\n\n* History of attempted suicide or suicidal ideation with plan (i.e., active suicidal ideation) that required hospital visit and/or change in level of care within 12 months prior to screening.\n* Current active psychosis, confusional state, or violent behavior.\n* Any serious medical condition or clinically significant laboratory, vital signs, or ECG abnormalities at screening that, in the Investigator\'s judgment, precludes the patient\'s safe participation in and completion of the study.\n* Clinical diagnosis of chronic migraines or history of low pressure headache after lumbar puncture requiring hospitalization or blood patch.\n* Treatment with investigational therapy within 4 weeks prior to screening or 5 drug elimination half-lives of investigational therapy, whichever is longer.\n* Concurrent or planned concurrent participation in any interventional clinical study, including explicit pharmacological and non-pharmacological interventions. Observational studies are acceptable.\n* Unable or unsafe to perform lumbar puncture on the patient.\n* Previous lumbar surgery that is likely, in the opinion of the Investigator or surgical team, to make IT catheter insertion or IT injection unduly difficult or hazardous.\n* Poor peripheral venous access.\n* Scoliosis or spinal deformity making IT injection not feasible in the outpatient setting.\n* Preexisting intra-axial or extra-axial lesions as assessed by a centrally read MRI scan during the screening period.'}, 'identificationModule': {'nctId': 'NCT04000594', 'briefTitle': "A Study to Investigate the Pharmacokinetics and Pharmacodynamics of RO7234292 (RG6042) in CSF and Plasma, and Safety and Tolerability Following Intrathecal Administration in Patients With Huntington's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': "An Open-Label Adaptive Multiple-Dose Study to Investigate the Pharmacokinetics and Pharmacodynamics of RO7234292 in CSF and Plasma, and Safety and Tolerability Following Intrathecal Administration in Patients With Huntington's Disease", 'orgStudyIdInfo': {'id': 'BP40410'}, 'secondaryIdInfos': [{'id': 'GEN-PEAK', 'type': 'OTHER', 'domain': 'Hoffmann-La Roche'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose level 1 of RO7234292 (RG6042)', 'description': 'Participants will receive dose level 1 of RO7234292 (RG6042) intrathecally on Day 1 and Day 29.', 'interventionNames': ['Drug: RO7234292 (RG6042)']}, {'type': 'EXPERIMENTAL', 'label': 'Dose level 2 of RO7234292 (RG6042)', 'description': 'Participants will receive dose level 2 of RO7234292 (RG6042) intrathecally on Day 1 and Day 29.', 'interventionNames': ['Drug: RO7234292 (RG6042)']}, {'type': 'EXPERIMENTAL', 'label': 'Dose level 3 of RO7234292 (RG6042)', 'description': 'Participants will receive dose level 3 of RO7234292 (RG6042) intrathecally on Day 1 and Day 29.', 'interventionNames': ['Drug: RO7234292 (RG6042)']}], 'interventions': [{'name': 'RO7234292 (RG6042)', 'type': 'DRUG', 'otherNames': ['Tominersen'], 'description': 'RO7234292 (RG6042) will be administered in two IT doses of the same dose level at an interval of 28 days during the treatment period (Day 1 and Day 29). Each dose of RO7234292 (RG6042) will be administered as a single IT bolus injection.', 'armGroupLabels': ['Dose level 1 of RO7234292 (RG6042)', 'Dose level 2 of RO7234292 (RG6042)', 'Dose level 3 of RO7234292 (RG6042)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2333', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Centre For Human Drug Research; Research', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': 'WC1N 3BG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Leonard Wolfson Experimental Neurology Centre', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester University NHS Foundation Trust (MFT)', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\\_and\\_development/who\\_we\\_are\\_how\\_we\\_work/clinical\\_trials/our\\_commitment\\_to\\_data\\_sharing.htm)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}