Summary

for people ages 18-75 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Michael Geschwind

Description

Summary

The primary purpose of this study is to compare the efficacy of BHV-4157 versus placebo after 8 weeks of treatment on ataxia symptoms in subjects with spinocerebellar ataxia (SCA).

Official Title

A Phase IIb/III, Randomized, Double-blind, Placebo-controlled Trial of BHV-4157 in Adult Subjects With Spinocerebellar Ataxia

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 Ataxia SCA Spinocerebellar Ataxia Cerebellar Ataxia Spinocerebellar Degenerations BHV-4157

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 (A Maximum of 12 patients will be enrolled with this genotype- FEB 1 2017 -THIS CAP HAS BEEN MET FOR SCA3), SCA6, SCA7, SCA8 and SCA10
  • Ability to ambulate 8 meters without assistance (canes and other devices allowed)
  • Screening total SARA total score ≥8
  • Determined by the investigator to be medically stable at baseline/randomization and must be physically able and expected to complete the trial as designed
  • Subjects must have adequate hearing, vision, and language skills to perform Scale for the Assessment and Rating of Ataxia (SARA) ratings, 8 Meter Walk Test and other neuropsychiatric testing and interviews as specified in the protocol

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, San Francisco
    San Francisco California 94158 United States
  • University of California, Los Angeles
    Los Angeles California 90095 United States
  • CNS Trial
    Long Beach California 90806 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
Lead Scientist
Michael Geschwind
Study Type
Interventional
Last Updated
August 6, 2018