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

Lead Scientist

  • Michael Geschwind
    Dr. Geschwind received his M.D.and Ph.D. in neuroscience through the National Institutes of Health (NIH)-sponsored Medical Scientist Training Program (MSTP) at the Albert Einstein College of Medicine in New York.

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