Trial in Adult Participants With Spinocerebellar Ataxia (SCA)
NCT ID: NCT02960893
Last Updated: 2025-10-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
141 participants
INTERVENTIONAL
2016-12-15
2024-09-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Troriluzole - Randomization Phase
Troriluzole - Randomization Phase: Participants received Troriluzole 140 mg capsules orally once daily (QD) for 8 weeks.
Troriluzole
Randomization Phase: Neat (i.e., drug substance without excipients); loose filled capsule.
Placebo - Randomization Phase
Placebo - Randomization Phase: Participants received matching placebo capsules orally QD for 8 weeks.
Placebo
Drug: Placebo Randomization Phase: Matching placebo loose filled capsule.
Troriluzole/Troriluzole - OLE (Open Label Extension) Phase
Participants received Troriluzole 140 mg capsules orally QD for 48 weeks in the extension period and were allowed to participate in 288 weeks for expanded extension phase, for a total of 336 weeks of open-label treatment.
Troriluzole
Randomization Phase: Neat (i.e., drug substance without excipients); loose filled capsule.
Troriluzole
OLE phase: Neat capsule or formulated capsule (i.e., drug substance with excipients).
Placebo/Troriluzole - OLE Phase
Participants who received placebo during randomization phase, received Troriluzole 140 mg capsules orally QD for 48 weeks in the extension period and were allowed to participate in 288 weeks for expanded extension phase, for a total of 336 weeks of open-label treatment.
Placebo
Drug: Placebo Randomization Phase: Matching placebo loose filled capsule.
Troriluzole
OLE phase: Neat capsule or formulated capsule (i.e., drug substance with excipients).
Interventions
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Troriluzole
Randomization Phase: Neat (i.e., drug substance without excipients); loose filled capsule.
Placebo
Drug: Placebo Randomization Phase: Matching placebo loose filled capsule.
Troriluzole
OLE phase: Neat capsule or formulated capsule (i.e., drug substance with excipients).
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Biohaven Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
CNS Trial
Long Beach, California, United States
University of California, Los Angeles
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado Denver
Denver, Colorado, United States
University of Florida
Gainesville, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Harvard University (Massachusetts General Hospital)
Boston, Massachusetts, United States
Harvard University (Beth Israel Deaconess Medical Center)
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Columbia University
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
University of Texas Southwestern
Dallas, Texas, United States
Houston Methodist Research Center
Houston, Texas, United States
Countries
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References
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Schmahmann JD, Pierce S, MacMore J, L'Italien GJ. Development and Validation of a Patient-Reported Outcome Measure of Ataxia. Mov Disord. 2021 Oct;36(10):2367-2377. doi: 10.1002/mds.28670. Epub 2021 Jun 11.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BHV4157-201
Identifier Type: -
Identifier Source: org_study_id
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