Clinical Trial Details

Overview

Research Study Summary

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

Purpose
The purpose of this study is to compare the efficacy of BHV-4157 versus placebo on ataxia symptoms in subjects with spinocerebellar ataxia (SCA).
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CW ID: 222923
Date Last Changed: February 3, 2017

Clinical Trial Snapshot

Phase
2/3
Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Biohaven Pharmaceutical Holding Company Ltd
Facility Type
N/A

Eligibility

Inclusion Criteria:

  • 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 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

    Exclusion Criteria:

  • 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
  • Contact

    Kevin Allison or Mary Freeman
    University of South Florida - Morsani Center for Advanced Healthcare
    13330 USF Laurel Dr
    Tampa, FL 33612
    Phone: (813) 974-5909

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