At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 141 enrolled
Drug / intervention
Troriluzole +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IIb/III, Randomized, Double-blind, Placebo-controlled Trial of Troriluzole in Adult Participants With Spinocerebellar Ataxia
In Brief
A Phase 3 clinical trial evaluating Troriluzole and Placebo for Spinocerebellar Ataxias and 7 related conditions. Completed, enrolled 141 participants across 18 sites.
Detailed Summary
The primary purpose of this study was to compare the efficacy of BHV-4157 (Troriluzole) 140 milligrams (mg) once daily versus placebo after 8 weeks of treatment in participants with spinocerebellar ataxia (SCA).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinocerebellar Ataxias, Spinocerebellar Ataxia Genotype Type 1, Spinocerebellar Ataxia Genotype Type 2, Spinocerebellar Ataxia Genotype Type 3, Spinocerebellar Ataxia Genotype Type 6, Spinocerebellar Ataxia Genotype Type 7, Spinocerebellar Ataxia Genotype Type 8, Spinocerebellar Ataxia Genotype Type 10
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 2016
Enrollment StartDec 2016
Primary CompletionAug 2017
Study CompletionSep 2024
TodayJul 2026
First PostedNov 10, 2016
Enrollment StartDec 15, 2016
Primary CompletionAug 18, 2017
Study CompletionSep 20, 2024
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.6 years ago
Interventions
Troriluzoledrug
Randomization Phase: Neat (i.e., drug substance without excipients); loose filled capsule.
Placebodrug
Drug: Placebo Randomization Phase: Matching placebo loose filled capsule.
Troriluzoledrug
OLE phase: Neat capsule or formulated capsule (i.e., drug substance with excipients).