A Phase IIb/III, Randomized, Double-blind, Placebo-controlled Trial of Troriluzole in Adult Subjects With Spinocerebellar Ataxia

BHV4157-201

The primary purpose of this study is to compare the efficacy of BHV-4157 (Troriluzole) 140 milligrams (mg) once daily versus placebo after 8 weeks of treatment in subjects with spinocerebellar ataxia (SCA).

2016-12-15

2017-08-18

2024-09-23

Active (not recruiting)

Early phase I

141

Key Inclusion Criteria: * Subjects with a known or suspected diagnosis of the following specific hereditary ataxias: SCA1, SCA2, SCA3, SCA6, SCA7, SCA8 and SCA10 * Ability to ambulate 8 meters without assistance (canes and other devices allowed) * Screening total Scale for the Assessment and Rating of Ataxia (SARA) score ≥8 * Score of ≥ 2 on the gait subsection of the SARA * Determined by the investigator to be medically stable at baseline/randomization and must be physically able and expected to complete the trial as designed Key Exclusion Criteria: * Any medical condition other than one of the hereditary ataxias specified in the inclusion criteria that could predominantly explain or contribute significantly to the subjects' symptoms of ataxia * Mini Mental State Exam (MMSE) score \< 24 * SARA total score of \> 30 points at screening * Clinical history of stroke * Active liver disease or a history of hepatic intolerance to medications that in the investigator's judgment, is medically significant

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 141, 'type': 'ACTUAL'}}

2024-04-15