Trial in Adult Participants With Spinocerebellar Ataxia (SCA) (NCT02960893) | Clinical Trial Compass
CompletedPhase 2/3
Trial in Adult Participants With Spinocerebellar Ataxia (SCA)
United States141 participantsStarted 2016-12-15
Plain-language summary
The primary purpose of this study was to compare the efficacy of BHV-4157 (Troriluzole) 140 milligrams (mg) once daily versus placebo after 8 weeks of treatment in participants with spinocerebellar ataxia (SCA).
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Participants 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 participants 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
What they're measuring
1
Change From Baseline in Total Score on the Scale for the Assessment and Rating of Ataxia (SARA) at Randomization Phase Week 8