Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UCLA UCSF
Dates
study started
estimated completion

Description

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).

Official Title

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

Details

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.

Keywords

Spinocerebellar 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 Spinocerebellar Ataxia SCA Ataxia Cerebellar Ataxia Spinocerebellar Degenerations Troriluzole

Eligibility

You can join if…

Open to people ages 18-75

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California, Los Angeles
    Los Angeles California 90095 United States
  • University of California, San Francisco
    San Francisco California 94158 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Biohaven Pharmaceuticals, Inc.
ID
NCT02960893
Phase
Phase 2/3
Study Type
Interventional
Last Updated