Open
Actively Recruiting
Trial in Adult Subjects With Spinocerebellar Ataxia
About
Brief 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).
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Key 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 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
Key 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
- 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
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Study Stats
Protocol No.
16-001331
Category
Brain/Neurological Diseases
Principal Investigator
Contact
Location
- UCLA Westwood