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Trial in Adult Subjects With Spinocerebellar Ataxia

Spinocerebellar Ataxias Clinical Trial

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

Clinical Trial Summary

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).

Clinical Trial Description

The study was conducted in 2 phases: Randomization Phase (8 weeks) followed by an open-label Extension Phase (48 weeks). During the Randomization Phase, participants received either Troriluzole 140 mg or matching placebo up to 8 weeks. Participants who agreed to enter the Extension Phase continued dosing of Troriluzole 140 mg for 48 weeks. The study was subsequently amended to follow participants for a total of 192 weeks in the Extension Phase. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02960893
Study type Interventional
Source Biohaven Pharmaceuticals, Inc.
Contact
Status Active, not recruiting
Phase Phase 2/Phase 3
Start date December 15, 2016
Completion date September 23, 2024
View Details
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