Skip to main content

Summary

Eligibility
for people ages 18–75
Location
at San Francisco, California and other locations
Dates
study started
Principal Investigator

Description

Summary

The purpose of this study is to compare the efficacy of BHV-4157 versus placebo 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 Type 1 Spinocerebellar Ataxia Type 2 Spinocerebellar Ataxia Type 3 Spinocerebellar Ataxia Type 6 Spinocerebellar Ataxia Type 7 Spinocerebellar Ataxia Type 8 Spinocerebellar Ataxia Type 10 Ataxia SCA Spinocerebellar Ataxia

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 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
  • 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
  • CNS Trial
    Long Beach, California, 90806, United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Biohaven Pharmaceutical Holding Company Ltd.
ID
NCT02960893
Phase
Phase 2/3
Lead Scientist
Michael Geschwind
Study Type
Interventional
Last Updated
June 1, 2017