Trial in Adult Subjects With Spinocerebellar Ataxia

• Status: Active, not recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biohaven Pharmaceutical Holding Company Ltd.; Biohaven Pharmaceuticals, Inc.
• Collaborators: Cognitive Research Corporation; Cytel Inc.

Criteria

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