Viewing Study NCT02255435

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Ignite Creation Date: 2025-12-24 @ 10:16 PM
Ignite Modification Date: 2026-02-02 @ 12:44 PM
Study NCT ID: NCT02255435
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2025-10-07
First Post: 2014-09-30
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study to Learn About the Effects and Safety of RTA 408 (Omaveloxolone) in People Aged 16 to 40 With Friedreich's Ataxia
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005621', 'term': 'Friedreich Ataxia'}, {'id': 'D028361', 'term': 'Mitochondrial Diseases'}], 'ancestors': [{'id': 'D013132', 'term': 'Spinocerebellar Degenerations'}, {'id': 'D002526', 'term': 'Cerebellar Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'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': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000589490', 'term': 'omaveloxolone'}, {'id': 'C116742', 'term': 'ORF 50 transactivator'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@biogen.com', 'phone': '866-633-4636', 'title': 'US Biogen Clinical Trial Center', 'organization': 'Biogen'}, 'certainAgreement': {'otherDetails': "Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '16 weeks for Part 1 and 52 weeks for Part 2', 'description': 'After the first dose, documentation of adverse events was to continue until 30 days following administration of the final dose of study medication, regardless of their relationship to study drug or their clinical significance.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1 Omaveloxolone Capsules 2.5 and 5 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 2.5 mg administered orally one daily for 2 weeks, then 5 mg administered orally once daily for 10 weeks\n\nOmaveloxolone Capsules, 2.5 mg\n\nOmaveloxolone Capsules, 5 mg', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part 1 Omaveloxolone Capsules 10 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 10 mg administered orally once daily for 12 weeks\n\nOmaveloxolone Capsules, 10 mg', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part 1 Omaveloxolone Capsules 20 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 20 mg administered orally once daily for 12 weeks\n\nOmaveloxolone Capsules, 20 mg', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part 1 Omaveloxolone Capsules 40 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 40 mg administered orally once daily for 12 weeks\n\nOmaveloxolone Capsules, 40 mg', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part 1 Omaveloxolone Capsules 80 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 80 mg administered orally once daily for 12 weeks\n\nOmaveloxolone Capsules, 80 mg', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part 1 Omaveloxolone Capsules 160 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 160 mg administered orally once daily for 12 weeks\n\nOmaveloxolone Capsules, 160 mg', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 11, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part 1 Omaveloxolone Capsules 300 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 300 mg administered orally once daily for 12 weeks\n\nOmaveloxolone Capsules, 300 mg', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Part 1 Placebo Capsules', 'description': 'Placebo capsules administered orally once daily for 12 weeks\n\nPlacebo', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 16, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG008', 'title': 'Part 2 Placebo Capsules', 'description': 'Placebo capsules administered orally once daily for 48 weeks\n\nPlacebo', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 52, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG009', 'title': 'Part 2 Omaveloxolone Capsules 150 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 150 mg administered orally once daily for 48 weeks\n\nOmaveloxolone Capsules, 150 mg', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 51, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': "Friedreich's ataxia", 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 51, 'numEvents': 21, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Abnormal faeces', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 51, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 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time, and the interaction between treatment and time were used as fixed factors.'}, {'pValue': '0.7937', 'groupIds': ['OG003', 'OG007'], 'paramType': 'LS Mean difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.15', 'estimateComment': 'Difference is omaveloxolone - placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, time, and the interaction between treatment and time were used as fixed factors.'}, {'pValue': '0.5587', 'groupIds': ['OG004', 'OG007'], 'paramType': 'LS Mean difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.10', 'estimateComment': 'Difference is omaveloxolone - placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, time, and the interaction between treatment and time were used as fixed factors.'}, {'pValue': '0.7285', 'groupIds': ['OG005', 'OG007'], 'paramType': 'LS Mean difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.09', 'estimateComment': 'Difference is omaveloxolone - placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, time, and the interaction between treatment and time were used as fixed factors.'}, {'pValue': '0.5802', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS Mean difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.15', 'estimateComment': 'Difference is omaveloxolone - placebo', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, time, and the interaction between treatment and time were used as fixed factors.'}, {'pValue': '0.9698', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007'], 'paramType': 'LS Mean difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.00', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.08', 'estimateComment': 'Difference is omaveloxolone - placebo', 'groupDescription': 'Comparison of Omaveloxolone capsules pooled with Placebo capsules', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, time, and the interaction between treatment and time were used as fixed factors.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline through 12 weeks after participant receives the first dose in Part 1.', 'description': 'Peak work attained during maximal exercise testing. Cycle ergometry using a recumbent stationary bicycle was used, and workload was increased incrementally. Peak work is defined as the workload at which patients reach maximal volition (defined as an inability to continue to exercise due to exhaustion).', 'unitOfMeasure': 'W/kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients in Part 1, whether or not they received study drug'}, {'type': 'PRIMARY', 'title': "Change in the Modified Friedreich's Ataxia Rating Scale (mFARS) at Week 48 in Part 2", 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Placebo Capsules', 'description': 'Placebo capsules administered orally once daily for 48 weeks\n\nPlacebo'}, {'id': 'OG001', 'title': 'Part 2 Omaveloxolone Capsules 150 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 150 mg administered orally once daily for 48 weeks\n\nOmaveloxolone Capsules, 150 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.85', 'spread': '0.640', 'groupId': 'OG000'}, {'value': '-1.55', 'spread': '0.689', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0141', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.40', 'ciLowerLimit': '-4.31', 'ciUpperLimit': '-0.50', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.956', 'estimateComment': 'Difference is omaveloxolone - placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Fixed factors: treatment group, time, interaction between treatment and time, interaction between baseline and time; covariates: site, baseline mFARS'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '48 weeks after participant receives the first dose in Part 2', 'description': "The mFARS includes 4 of the 5 sections of the Friedreich's Ataxia Rating Scale (FARS): bulbar (score 0 to 11), upper limb coordination (score 0 to 36), lower limb coordination (score 0 to 16), and upright stability (score 0 to 36). The minimum score is 0 and the maximum score is 99. A lower score indicates better neurological function.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (all patients in Part 2 randomized without pes cavus who have at least one post-baseline measurement)'}, {'type': 'SECONDARY', 'title': "Change in the Modified Friedreich's Ataxia Rating Scale (mFARS) at Week 12 in Part 1", 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Omaveloxolone Capsules 2.5 and 5 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 2.5 mg administered orally one daily for 2 weeks, then 5 mg administered orally once daily for 10 weeks\n\nOmaveloxolone Capsules, 2.5 mg\n\nOmaveloxolone Capsules, 5 mg'}, {'id': 'OG001', 'title': 'Part 1 Omaveloxolone Capsules 10 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 10 mg administered orally once daily for 12 weeks\n\nOmaveloxolone Capsules, 10 mg'}, {'id': 'OG002', 'title': 'Part 1 Omaveloxolone Capsules 20 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 20 mg administered orally once daily for 12 weeks\n\nOmaveloxolone Capsules, 20 mg'}, {'id': 'OG003', 'title': 'Part 1 Omaveloxolone Capsules 40 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 40 mg administered orally once daily for 12 weeks\n\nOmaveloxolone Capsules, 40 mg'}, {'id': 'OG004', 'title': 'Part 1 Omaveloxolone Capsules 80 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 80 mg administered orally once daily for 12 weeks\n\nOmaveloxolone Capsules, 80 mg'}, {'id': 'OG005', 'title': 'Part 1 Omaveloxolone Capsules 160 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 160 mg administered orally once daily for 12 weeks\n\nOmaveloxolone Capsules, 160 mg'}, {'id': 'OG006', 'title': 'Part 1 Omaveloxolone Capsules 300 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 300 mg administered orally once daily for 12 weeks\n\nOmaveloxolone Capsules, 300 mg'}, {'id': 'OG007', 'title': 'Part 1 Placebo Capsules', 'description': 'Placebo capsules administered orally once daily for 12 weeks\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.26', 'groupId': 'OG000', 'lowerLimit': '-5.82', 'upperLimit': '-0.70'}, {'value': '-1.97', 'groupId': 'OG001', 'lowerLimit': '-4.53', 'upperLimit': '0.59'}, {'value': '-2.44', 'groupId': 'OG002', 'lowerLimit': '-5.00', 'upperLimit': '0.12'}, {'value': '-2.4', 'groupId': 'OG003', 'lowerLimit': '-4.96', 'upperLimit': '0.16'}, {'value': '-2.88', 'groupId': 'OG004', 'lowerLimit': '-5.44', 'upperLimit': '-0.31'}, {'value': '-3.75', 'groupId': 'OG005', 'lowerLimit': '-5.56', 'upperLimit': '-1.94'}, {'value': '-0.88', 'groupId': 'OG006', 'lowerLimit': '-2.86', 'upperLimit': '1.11'}, {'value': '-1.43', 'groupId': 'OG007', 'lowerLimit': '-2.97', 'upperLimit': '0.11'}]}]}], 'analyses': [{'pValue': '0.2310', 'groupIds': ['OG000', 'OG007'], 'paramType': 'LS Mean difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.81', 'ciLowerLimit': '-4.80', 'ciUpperLimit': '1.18', 'estimateComment': 'Difference is omaveloxolone - placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, time, and the interaction between treatment and time were used as fixed factors.'}, {'pValue': '0.7298', 'groupIds': ['OG001', 'OG007'], 'paramType': 'LS Mean difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-3.51', 'ciUpperLimit': '2.47', 'estimateComment': 'Difference is omaveloxolone - placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, time, and the interaction between treatment and time were used as fixed factors.'}, {'pValue': '0.5102', 'groupIds': ['OG002', 'OG007'], 'paramType': 'LS Mean difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.99', 'ciLowerLimit': '-3.99', 'ciUpperLimit': '2.00', 'estimateComment': 'Difference is omaveloxolone - placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, time, and the interaction between treatment and time were used as fixed factors.'}, {'pValue': '0.5281', 'groupIds': ['OG003', 'OG007'], 'paramType': 'LS Mean difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.95', 'ciLowerLimit': '-3.94', 'ciUpperLimit': '2.04', 'estimateComment': 'Difference is omaveloxolone - placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, time, and the interaction between treatment and time were used as fixed factors.'}, {'pValue': '0.3458', 'groupIds': ['OG004', 'OG007'], 'paramType': 'LS Mean difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.42', 'ciLowerLimit': '-4.42', 'ciUpperLimit': '1.57', 'estimateComment': 'Difference is omaveloxolone - placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, time, and the interaction between treatment and time were used as fixed factors.'}, {'pValue': '0.0587', 'groupIds': ['OG005', 'OG007'], 'paramType': 'LS Mean difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.30', 'ciLowerLimit': '-4.68', 'ciUpperLimit': '0.09', 'estimateComment': 'Difference is omaveloxolone - placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, time, and the interaction between treatment and time were used as fixed factors.'}, {'pValue': '0.6480', 'groupIds': ['OG006', 'OG007'], 'paramType': 'LS Mean difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '-1.94', 'ciUpperLimit': '3.10', 'estimateComment': 'Difference is omaveloxolone - placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, time, and the interaction between treatment and time were used as fixed factors.'}, {'pValue': '0.2174', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006', 'OG007'], 'paramType': 'LS Mean difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.10', 'ciLowerLimit': '-2.87', 'ciUpperLimit': '0.66', 'estimateComment': 'Difference is omaveloxolone - placebo.', 'groupDescription': 'Comparison of Omaveloxolone capsules pooled with Placebo capsules', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment group, time, and the interaction between treatment and time were used as fixed factors.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 weeks after participant receives the first dose in Part 1', 'description': "The mFARS includes 4 of the 5 sections of the Friedreich's Ataxia Rating Scale (FARS): bulbar (score 0 to 11), upper limb coordination (score 0 to 36), lower limb coordination (score 0 to 16), and upright stability (score 0 to 36). The minimum score is 0 and the maximum score is 99. A lower score indicates better neurological function.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients in Part 1, whether or not they received study drug'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1 Omaveloxolone Capsules 2.5 and 5 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 2.5 mg administered orally one daily for 2 weeks, then 5 mg administered orally once daily for 10 weeks\n\nOmaveloxolone Capsules, 2.5 mg\n\nOmaveloxolone Capsules, 5 mg'}, {'id': 'FG001', 'title': 'Part 1 Omaveloxolone Capsules 10 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 10 mg administered orally once daily for 12 weeks\n\nOmaveloxolone Capsules, 10 mg'}, {'id': 'FG002', 'title': 'Part 1 Omaveloxolone Capsules 20 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 20 mg administered orally once daily for 12 weeks\n\nOmaveloxolone Capsules, 20 mg'}, {'id': 'FG003', 'title': 'Part 1 Omaveloxolone Capsules 40 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 40 mg administered orally once daily for 12 weeks\n\nOmaveloxolone Capsules, 40 mg'}, {'id': 'FG004', 'title': 'Part 1 Omaveloxolone Capsules 80 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 80 mg administered orally once daily for 12 weeks\n\nOmaveloxolone Capsules, 80 mg'}, {'id': 'FG005', 'title': 'Part 1 Omaveloxolone Capsules 160 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 160 mg administered orally once daily for 12 weeks\n\nOmaveloxolone Capsules, 160 mg'}, {'id': 'FG006', 'title': 'Part 1 Omaveloxolone Capsules 300 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 300 mg administered orally once daily for 12 weeks\n\nOmaveloxolone Capsules, 300 mg'}, {'id': 'FG007', 'title': 'Part 1 Placebo Capsules', 'description': 'Placebo capsules administered orally once daily for 12 weeks\n\nPlacebo'}, {'id': 'FG008', 'title': 'Part 2 Placebo Capsules', 'description': 'Placebo capsules administered orally once daily for 48 weeks\n\nPlacebo'}, {'id': 'FG009', 'title': 'Part 2 Omaveloxolone Capsules 150 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 150 mg administered orally once daily for 48 weeks\n\nOmaveloxolone Capsules, 150 mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '12'}, {'groupId': 'FG006', 'numSubjects': '10'}, {'groupId': 'FG007', 'numSubjects': '17'}, {'groupId': 'FG008', 'numSubjects': '52'}, {'groupId': 'FG009', 'numSubjects': '51'}]}, {'type': 'Number of Participants With Pes Cavus', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '10'}, {'groupId': 'FG008', 'numSubjects': '10'}, {'groupId': 'FG009', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '12'}, {'groupId': 'FG006', 'numSubjects': '10'}, {'groupId': 'FG007', 'numSubjects': '16'}, {'groupId': 'FG008', 'numSubjects': '51'}, {'groupId': 'FG009', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': "Patient's Limited Time Availability", 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '4'}]}, {'type': 'Administrative reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'MOXIe Part 1 and Part 2 were conducted under the same protocol. Participants enrolled in Part 1 were not allowed to enroll in Part 2. Patients with pes cavus were not to comprise more than 20% of all patients enrolled in Part 2.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '17', 'groupId': 'BG007'}, {'value': '52', 'groupId': 'BG008'}, {'value': '51', 'groupId': 'BG009'}, {'value': '172', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1 Omaveloxolone Capsules 2.5 and 5 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 2.5 mg administered orally one daily for 2 weeks, then 5 mg administered orally once daily for 10 weeks\n\nOmaveloxolone Capsules, 2.5 mg\n\nOmaveloxolone Capsules, 5 mg'}, {'id': 'BG001', 'title': 'Part 1 Omaveloxolone Capsules 10 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 10 mg administered orally once daily for 12 weeks\n\nOmaveloxolone Capsules, 10 mg'}, {'id': 'BG002', 'title': 'Part 1 Omaveloxolone Capsules 20 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 20 mg administered orally once daily for 12 weeks\n\nOmaveloxolone Capsules, 20 mg'}, {'id': 'BG003', 'title': 'Part 1 Omaveloxolone Capsules 40 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 40 mg administered orally once daily for 12 weeks\n\nOmaveloxolone Capsules, 40 mg'}, {'id': 'BG004', 'title': 'Part 1 Omaveloxolone Capsules 80 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 80 mg administered orally once daily for 12 weeks\n\nOmaveloxolone Capsules, 80 mg'}, {'id': 'BG005', 'title': 'Part 1 Omaveloxolone Capsules 160 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 160 mg administered orally once daily for 12 weeks\n\nOmaveloxolone Capsules, 160 mg'}, {'id': 'BG006', 'title': 'Part 1 Omaveloxolone Capsules 300 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 300 mg administered orally once daily for 12 weeks\n\nOmaveloxolone Capsules, 300 mg'}, {'id': 'BG007', 'title': 'Part 1 Placebo Capsules', 'description': 'Placebo capsules administered orally once daily for 12 weeks\n\nPlacebo'}, {'id': 'BG008', 'title': 'Part 2 Placebo Capsules', 'description': 'Placebo capsules administered orally once daily for 48 weeks\n\nPlacebo'}, {'id': 'BG009', 'title': 'Part 2 Omaveloxolone Capsules 150 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 150 mg administered orally once daily for 48 weeks\n\nOmaveloxolone Capsules, 150 mg'}, {'id': 'BG010', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.8', 'spread': '5.98', 'groupId': 'BG000'}, {'value': '25.5', 'spread': '7.4', 'groupId': 'BG001'}, {'value': '28.3', 'spread': '6.8', 'groupId': 'BG002'}, {'value': '27.7', 'spread': '7.53', 'groupId': 'BG003'}, {'value': '24.3', 'spread': '4.8', 'groupId': 'BG004'}, {'value': '25.3', 'spread': '6.51', 'groupId': 'BG005'}, {'value': '25.6', 'spread': '7.24', 'groupId': 'BG006'}, {'value': '24.4', 'spread': '6.74', 'groupId': 'BG007'}, {'value': '24.1', 'spread': '7.85', 'groupId': 'BG008'}, {'value': '23.4', 'spread': '6.08', 'groupId': 'BG009'}, {'value': '24.5', 'spread': '6.84', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '17', 'groupId': 'BG008'}, {'value': '31', 'groupId': 'BG009'}, {'value': '85', 'groupId': 'BG010'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '35', 'groupId': 'BG008'}, {'value': '20', 'groupId': 'BG009'}, {'value': '87', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '7', 'groupId': 'BG010'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}, {'value': '49', 'groupId': 'BG008'}, {'value': '49', 'groupId': 'BG009'}, {'value': '165', 'groupId': 'BG010'}]}, {'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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}]}]}], '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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}]}, {'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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}]}, {'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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}]}, {'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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}, {'value': '50', 'groupId': 'BG008'}, {'value': '50', 'groupId': 'BG009'}, {'value': '167', 'groupId': 'BG010'}]}, {'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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}]}, {'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': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '14', 'groupId': 'BG010'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}, {'value': '35', 'groupId': 'BG008'}, {'value': '36', 'groupId': 'BG009'}, {'value': '131', 'groupId': 'BG010'}]}]}, {'title': 'United Kingdom', 'categories': [{'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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}]}]}, {'title': 'Italy', 'categories': [{'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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '7', 'groupId': 'BG010'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '12', 'groupId': 'BG010'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Peak Work', 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '0.696', 'groupId': 'BG000'}, {'value': '0.78', 'spread': '0.677', 'groupId': 'BG001'}, {'value': '1.25', 'spread': '0.838', 'groupId': 'BG002'}, {'value': '0.72', 'spread': '0.565', 'groupId': 'BG003'}, {'value': '1.6', 'spread': '0.556', 'groupId': 'BG004'}, {'value': '1.18', 'spread': '0.646', 'groupId': 'BG005'}, {'value': '0.88', 'spread': '0.521', 'groupId': 'BG006'}, {'value': '0.99', 'spread': '0.637', 'groupId': 'BG007'}, {'value': '1.23', 'spread': '0.622', 'groupId': 'BG008'}, {'value': '1.09', 'spread': '0.576', 'groupId': 'BG009'}, {'value': '1.12', 'spread': '0.621', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'description': 'Peak work attained during maximal exercise testing. Cycle ergometry using a recumbent stationary bicycle was used, and workload was increased incrementally. Peak work is defined as the workload at which patients reach maximal volition (defined as an inability to continue to exercise due to exhaustion).', 'unitOfMeasure': 'W/kg', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized patients, whether or not they received study drug'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-21', 'size': 9896496, 'label': 'Study Protocol: Main Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-09-28T15:27', 'hasProtocol': True}, {'date': '2021-06-21', 'size': 14174325, 'label': 'Study Protocol: United Kingdom Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-09-28T15:28', 'hasProtocol': True}, {'date': '2017-05-15', 'size': 974841, 'label': 'Statistical Analysis Plan: Part 1', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-09-28T15:34', 'hasProtocol': False}, {'date': '2019-09-18', 'size': 6384334, 'label': 'Statistical Analysis Plan: Part 2', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-09-28T15:35', 'hasProtocol': False}, {'date': '2019-10-09', 'size': 192874, 'label': 'Statistical Analysis Plan: Part 2 Addendum', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_004.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-09-28T15:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'dispFirstSubmitDate': '2020-10-01', 'completionDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2014-09-30', 'dispFirstSubmitQcDate': '2020-10-01', 'resultsFirstSubmitDate': '2022-09-30', 'studyFirstSubmitQcDate': '2014-09-30', 'dispFirstPostDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2022-11-04', 'studyFirstPostDateStruct': {'date': '2014-10-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Peak Work (in Watts/kg) During Exercise Testing at Week 12 in Part 1', 'timeFrame': 'Baseline through 12 weeks after participant receives the first dose in Part 1.', 'description': 'Peak work attained during maximal exercise testing. Cycle ergometry using a recumbent stationary bicycle was used, and workload was increased incrementally. Peak work is defined as the workload at which patients reach maximal volition (defined as an inability to continue to exercise due to exhaustion).'}, {'measure': "Change in the Modified Friedreich's Ataxia Rating Scale (mFARS) at Week 48 in Part 2", 'timeFrame': '48 weeks after participant receives the first dose in Part 2', 'description': "The mFARS includes 4 of the 5 sections of the Friedreich's Ataxia Rating Scale (FARS): bulbar (score 0 to 11), upper limb coordination (score 0 to 36), lower limb coordination (score 0 to 16), and upright stability (score 0 to 36). The minimum score is 0 and the maximum score is 99. A lower score indicates better neurological function."}], 'secondaryOutcomes': [{'measure': "Change in the Modified Friedreich's Ataxia Rating Scale (mFARS) at Week 12 in Part 1", 'timeFrame': '12 weeks after participant receives the first dose in Part 1', 'description': "The mFARS includes 4 of the 5 sections of the Friedreich's Ataxia Rating Scale (FARS): bulbar (score 0 to 11), upper limb coordination (score 0 to 36), lower limb coordination (score 0 to 16), and upright stability (score 0 to 36). The minimum score is 0 and the maximum score is 99. A lower score indicates better neurological function."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['RTA 408', 'RTA 408 Capsules', 'Oxidative Stress', 'Mitochondrial dysfunction', 'omaveloxolone'], 'conditions': ['Friedreich Ataxia']}, 'referencesModule': {'references': [{'pmid': '33068037', 'type': 'DERIVED', 'citation': "Lynch DR, Chin MP, Delatycki MB, Subramony SH, Corti M, Hoyle JC, Boesch S, Nachbauer W, Mariotti C, Mathews KD, Giunti P, Wilmot G, Zesiewicz T, Perlman S, Goldsberry A, O'Grady M, Meyer CJ. Safety and Efficacy of Omaveloxolone in Friedreich Ataxia (MOXIe Study). Ann Neurol. 2021 Feb;89(2):212-225. doi: 10.1002/ana.25934. Epub 2020 Nov 5."}, {'pmid': '30656180', 'type': 'DERIVED', 'citation': "Lynch DR, Farmer J, Hauser L, Blair IA, Wang QQ, Mesaros C, Snyder N, Boesch S, Chin M, Delatycki MB, Giunti P, Goldsberry A, Hoyle C, McBride MG, Nachbauer W, O'Grady M, Perlman S, Subramony SH, Wilmot GR, Zesiewicz T, Meyer C. Safety, pharmacodynamics, and potential benefit of omaveloxolone in Friedreich ataxia. Ann Clin Transl Neurol. 2018 Nov 10;6(1):15-26. doi: 10.1002/acn3.660. eCollection 2019 Jan."}]}, 'descriptionModule': {'briefSummary': "In this study, researchers are learning more about RTA 408, also known as omaveloxolone, BIIB141, or SKYCLARYS®. The main goal of this study is to learn more about the safety of RTA 408 and how it affects physical effort, movement, coordination, and how participants feel in daily life.\n\nThe main questions researchers want to answer in this study are:\n\n* How much physical effort can a participant produce during a cycling test after 12 weeks of treatment?\n* How do scores on the modified Friedreich's Ataxia Rating Scale (mFARS) change after 48 weeks?\n\nResearchers will use the modified Friedreich's Ataxia Rating Scale (mFARS) to measure how FA affects the nervous system. The mFARS looks at movement ability, balance, coordination, speech, and how well the arms and legs work.\n\nThey will also use a cycling test to measure physical effort, along with questionnaires to learn how participants feel and function in daily life.\n\nSafety will also be tested using physical exams, vital sign checks, echocardiograms (ECHO), electrocardiograms (ECG), and blood and urine tests.\n\nThe study will be done in 2 main parts, followed by an optional Extension period:\n\n* In Part 1, participants will be randomly assigned to take different doses of RTA 408 or a placebo by mouth once a day for 12 weeks. A placebo looks like the study drug but contains no real medicine.\n* Researchers will compare these doses to decide which one to use in Part 2.\n* In Part 2, a different group of participants will take either the chosen dose of RTA 408 (150 mg) or placebo once a day for 48 weeks.\n* Participants who complete Part 1 or Part 2 may be able to join an Extension period, where everyone receives RTA 408.\n* In the Extension period, participants will continue to receive RTA 408 until the drug becomes commercially available or until they leave the study\n* Participants in Part 1 will have up to 9 study visits and 2 phone calls. If they do not move onto the Extension period, they will stay in the study for up to 20 weeks.\n* Participants in Part 2 will have up to 10 study visits and 3 phone calls. If they do not move onto the Extension period, they will stay in the study for up to 61 weeks.\n* Participants in the Extension period will have 2 visits in the first month, followed by visits every 6 months.", 'detailedDescription': "Friedreich's ataxia is an autosomal recessive cerebellar ataxia caused by triplet-repeat expansions. The causative mutation is a trinucleotide (GAA) repeat expansion in the first intron of the frataxin gene, leading to impaired transcription of frataxin. The pathological consequences of frataxin deficiency include a severe disruption of iron-sulfur cluster biosynthesis, mitochondrial iron overload coupled to cellular iron dysregulation, and an increased sensitivity to oxidative stress.\n\nA hallmark of Friedreich's ataxia is impairment of antioxidative defense mechanisms, which play a major role in disease progression. Studies have demonstrated that nuclear factor erythroid-derived 2-related factor 2 (Nrf2) signaling is grossly impaired in participants with Friedreich's ataxia. Therefore, the ability of omaveloxolone (RTA 408) to activate Nrf2 and induce antioxidant target genes is hypothesized to be therapeutic in participants with Friedreich's ataxia.\n\nThis 2-part study will evaluate the efficacy, safety, and pharmacodynamics of omaveloxolone (RTA 408) in the treatment of participants with Friedreich's ataxia.\n\nPart 1: The first part of this study will be a randomized, placebo-controlled, double-blind, dose-escalation study to evaluate the safety of omaveloxolone (RTA 408) at various doses in participants with Friedreich's ataxia.\n\nPart 2: The second part of this study is a randomized, placebo-controlled, double-blind, parallel-group study to evaluate the safety and efficacy of omaveloxolone (RTA 408) 150 mg in participants with Friedreich's ataxia. Participants enrolled in Part 2 will be randomized 1:1 to receive omaveloxolone (RTA 408) 150 mg or placebo.\n\nExtension: The extension will assess long-term safety and tolerability of omaveloxolone (RTA 408) in qualified participants with Friedreich's ataxia following completion of Part 1 or Part 2. Participants will not be unblinded to study treatment in Part 1 or Part 2 upon entering the extension study. Participants will receive open-label omaveloxolone (RTA 408) at 150 mg once daily."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Have genetically confirmed Friedreich's ataxia\n2. Have a modified FARS score ≥20 and ≤80\n3. Be male or female and ≥16 years of age and ≤40 years of age\n4. Have no changes to exercise regimen within 30 days prior to Study Day 1 and be willing to remain on the same exercise regimen during the 16-week study period\n5. Have the ability to complete maximal exercise testing\n6. Be able to swallow capsules\n\nExclusion Criteria:\n\n1. Have uncontrolled diabetes (HbA1c \\>11.0%)\n2. Have B-type natriuretic peptide value \\>200 pg/mL\n3. Have a history of clinically significant left-sided heart disease and/or clinically significant cardiac disease\n4. Have known active fungal, bacterial, and/or viral infection, including human immunodeficiency virus or hepatitis virus (B or C)\n5. Have known or suspected active drug or alcohol abuse\n6. Have clinically significant abnormalities of clinical hematology or biochemistry, including but not limited to elevations greater than 1.5 times the upper limit of normal of aspartate aminotransferase, or alanine aminotransferase\n7. Have any abnormal laboratory test value or serious pre-existing medical condition that, in the opinion of the investigator, would put the patient at risk by study enrollment\n8. Have taken any of the following drugs within 7 days prior to Study Day 1 or plan to take any of these drugs during the time of study participation:\n\n 1. Sensitive substrates for cytochrome P450 2C8 or 3A4 (e.g., repaglinide, midazolam, sildenafil)\n 2. Moderate or strong inhibitors or inducers of cytochrome P450 3A4 (e.g., carbamazepine, phenytoin, ciprofloxacin, grapefruit juice)\n 3. Substrates for p-glycoprotein transporter (e.g., ambrisentan, digoxin)\n9. Have participated in any other interventional clinical study within 30 days prior to Study Day 1\n10. Have a cognitive impairment that may preclude ability to comply with study procedures\n11. Prior participation in a trial with omaveloxolone (RTA 408)"}, 'identificationModule': {'nctId': 'NCT02255435', 'briefTitle': "A Study to Learn About the Effects and Safety of RTA 408 (Omaveloxolone) in People Aged 16 to 40 With Friedreich's Ataxia", 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': "A Phase 2 Study of the Safety, Efficacy, and Pharmacodynamics of RTA 408 in the Treatment of Friedreich's Ataxia (MOXIe)", 'orgStudyIdInfo': {'id': 'RTA 408-C-1402'}, 'secondaryIdInfos': [{'id': '2024-517436-22', 'type': 'OTHER', 'domain': 'EU CTIS Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 Omaveloxolone Capsules 2.5 and 5 mg', 'description': 'omaveloxolone (RTA 408) Capsules, 2.5 mg administered orally one daily for 2 weeks, then 5 mg taken orally once daily for 10 weeks', 'interventionNames': ['Drug: Omaveloxolone Capsules, 2.5 mg', 'Drug: Omaveloxolone Capsules, 5 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 Omaveloxolone Capsules 10 mg', 'description': 'omaveloxolone (RTA 408) Capsules, 10 mg administered orally once daily for 12 weeks', 'interventionNames': ['Drug: Omaveloxolone Capsules, 10 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 Omaveloxolone Capsules 20 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 20 mg administered orally once daily for 12 weeks', 'interventionNames': ['Drug: Omaveloxolone Capsules, 20 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 Omaveloxolone Capsules 40 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 40 mg administered orally once daily for 12 weeks', 'interventionNames': ['Drug: Omaveloxolone Capsules, 40 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 Omaveloxolone Capsules 80 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 80 mg administered orally once daily for 12 weeks', 'interventionNames': ['Drug: Omaveloxolone Capsules, 80 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 Omaveloxolone Capsules 160 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 160 mg administered orally once daily for 12 weeks', 'interventionNames': ['Drug: Omaveloxolone Capsules, 160 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 Omaveloxolone Capsules 300 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 300 mg administered orally once daily for 12 weeks', 'interventionNames': ['Drug: Omaveloxolone Capsules, 300 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 1 Placebo Capsules', 'description': 'Placebo capsules administered orally once daily for 12 weeks', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 2 Placebo Capsules', 'description': 'Placebo capsules administered orally once daily for 48 weeks', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 Omaveloxolone Capsules 150 mg', 'description': 'Omaveloxolone (RTA 408) Capsules, 150 mg administered orally once daily for 48 weeks', 'interventionNames': ['Drug: Omaveloxolone Capsules, 150 mg']}], 'interventions': [{'name': 'Omaveloxolone Capsules, 2.5 mg', 'type': 'DRUG', 'otherNames': ['RTA 408 Capsules 2.5 mg'], 'armGroupLabels': ['Part 1 Omaveloxolone Capsules 2.5 and 5 mg']}, {'name': 'Omaveloxolone Capsules, 5 mg', 'type': 'DRUG', 'otherNames': ['RTA 408 capsules, 5 mg'], 'armGroupLabels': ['Part 1 Omaveloxolone Capsules 2.5 and 5 mg']}, {'name': 'Omaveloxolone Capsules, 10 mg', 'type': 'DRUG', 'otherNames': ['RTA 408 capsules, 10 mg'], 'armGroupLabels': ['Part 1 Omaveloxolone Capsules 10 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Part 1 Placebo Capsules', 'Part 2 Placebo Capsules']}, {'name': 'Omaveloxolone Capsules, 20 mg', 'type': 'DRUG', 'otherNames': ['RTA 408 capsules, 20 mg'], 'armGroupLabels': ['Part 1 Omaveloxolone Capsules 20 mg']}, {'name': 'Omaveloxolone Capsules, 40 mg', 'type': 'DRUG', 'otherNames': ['RTA 408 capsules, 40 mg'], 'armGroupLabels': ['Part 1 Omaveloxolone Capsules 40 mg']}, {'name': 'Omaveloxolone Capsules, 80 mg', 'type': 'DRUG', 'otherNames': ['RTA 408 capsules, 80 mg'], 'armGroupLabels': ['Part 1 Omaveloxolone Capsules 80 mg']}, {'name': 'Omaveloxolone Capsules, 160 mg', 'type': 'DRUG', 'otherNames': ['RTA 408 capsules, 160 mg'], 'armGroupLabels': ['Part 1 Omaveloxolone Capsules 160 mg']}, {'name': 'Omaveloxolone Capsules, 300 mg', 'type': 'DRUG', 'otherNames': ['RTA 408 capsules, 300 mg'], 'armGroupLabels': ['Part 1 Omaveloxolone Capsules 300 mg']}, {'name': 'Omaveloxolone Capsules, 150 mg', 'type': 'DRUG', 'otherNames': ['RTA 408 capsules, 150 mg'], 'armGroupLabels': ['Part 2 Omaveloxolone Capsules 150 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida - 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