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Keep this study
Lead
Biohaven Pharmaceuticals, Inc.
The study was conducted in 2 phases: Randomization Phase (8 weeks) followed by an open-label Extension Phase (336 weeks). During the Randomization Phase, participants received either Troriluzole 140 mg or matching placebo up to 8 weeks. Participants who agreed to enter the Open-label Extension Phase continued dosing of Troriluzole 140 mg for 336 weeks. The study was subsequently amended to follow participants for a total of 336 weeks in the Open-label Extension Phase.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
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
