Status:
ACTIVE_NOT_RECRUITING
Real-World Data Study of Troriluzole-Treated Patients With Spinocerebellar Ataxia (SCA) Compared to a Matched Natural History Control
Lead Sponsor:
Biohaven Therapeutics Ltd.
Conditions:
Spinocerebellar Ataxias
Eligibility:
All Genders
18-75 years
Brief Summary
The purpose of this study is to leverage two sources of real-world data (RWD) to assess the effectiveness of troriluzole after three years of treatment in patients with SCA by comparison to an externa...
Detailed Description
This study comprises multiple sources of RWD including: 1) the Clinical Research Consortium for the Study of Cerebellar Ataxia (CRC-SCA/US SCA Natural History cohort; 2) the European Integrated Projec...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria for troriluzole-treated participants (BHV4157-206):
- Between the ages of 18-75
- Genetic confirmation of the following specific hereditary ataxias: SCA1, SCA2, SCA3, SCA6, SCA7, SCA8, and SCA10
- Screening f-SARA total score of ≥3 and score of ≥1 on gait item of the f-SARA.
- Ability to ambulate 8 meters without human assistance (canes and other devices were allowed)
- Subjects initially randomized to troriluzole
- Key Inclusion Criteria for participants selected from the natural history studies:
- Between ages of 18-75
- CRC-SCA: either a genetic confirmation or a diagnosis of SCA 1, 2, 3, 6, 7, 8, and 10 in themselves or a family member; EUROSCA: genetic confirmation of SCA genotypes 1, 2, 3 and 6.
- Key Exclusion Criteria for troriluzole-treated participants (BHV4157-206 study):
- Screening f-SARA score of 4 on any item of the f-SARA
- Any other medical condition that could predominantly explain or contribute significantly to the subjects' symptoms of ataxia or that could confound assessment of ataxia symptoms
- Key Exclusion Criteria for participants selected from the natural history studies:
- • Treatment with troriluzole
Exclusion
Key Trial Info
Start Date :
March 18 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
909 Patients enrolled
Trial Details
Trial ID
NCT06529146
Start Date
March 18 2019
End Date
June 1 2026
Last Update
January 9 2026
Active Locations (1)
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1
Biohaven
New Haven, Connecticut, United States, 06510