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NCT02960893 · ClinicalTrials.gov registry record · Phase 2
Trial in Adult Participants With Spinocerebellar Ataxia (SCA)
A Phase 2 study of Spinocerebellar Ataxias and Spinocerebellar Ataxia Genotype Type 1, sponsored by Biohaven Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 141
- Enrollment target
- 18
- Study locations
NCT02960893: Completed Phase 2 study of Spinocerebellar Ataxias and Spinocerebellar Ataxia Genotype Type 1, sponsored by Biohaven Pharmaceuticals.
NCT02960893 is a Phase 2 study of Spinocerebellar Ataxias and Spinocerebellar Ataxia Genotype Type 1 that has completed, run by Biohaven Pharmaceuticals. The registered enrollment target is 141 participants, below the 450-participant average among 5 other Spinocerebellar Ataxias trials with a reported enrollment target (69% lower). The trial reports 18 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02960893, a Phase 2 study of Spinocerebellar Ataxias and Spinocerebellar Ataxia Genotype Type 1, has completed, sponsored by Biohaven Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 141 participants
- Enrollment target
- 18
- Study locations
Study 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).
Primary Outcome
The severity of ataxia was assessed with the SARA, an 8-item clinical rating scale from 0 (no ataxia) to 40 (most severe ataxia). The total score was derived as the sum of the individual items, which included gait (0-8), stance (0-6), sitting (0-4), speech disturbance (0-6), finger chase (0-4), nose-finger test (0-4), fast alternating hand movements (0-4), and heel-shin slide (0-4). Since the finger chase, nose-finger test, fast alternating hand movements, and heel-shin slide were repeated on bo
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Troriluzole
Study Locations (18)
California
- CNS Trial - Long Beach
- University of California, Los Angeles - Los Angeles
- University of California, San Francisco - San Francisco
Florida
- University of Florida - Gainesville
- University of South Florida - Tampa
Illinois
- Northwestern University - Chicago
- University of Chicago - Chicago
Massachusetts
- Harvard University (Massachusetts General Hospital) - Boston
- Harvard University (Beth Israel Deaconess Medical Center) - Boston
New York
- Columbia University - New York
- University of Rochester Medical Center - Rochester
Texas
- University of Texas Southwestern - Dallas
- Houston Methodist Research Center - Houston
Arizona
- St. Joseph's Hospital and Medical Center - Phoenix
Colorado
- University of Colorado Denver - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2016-12-15 |
| Est. Completion | 2024-09-20 |
| Phase | Phase 2 |
What the finished NCT02960893 record still lists
NCT02960893 is an interventional study that assigns participants to a tested intervention. The registered 141 participants enrollment target is mid-sized for trials with a published cap, below the 450-participant average among 5 other Spinocerebellar Ataxias trials with a reported enrollment target (69% lower).
The record links to 8 conditions, with Spinocerebellar Ataxias appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02960893 lists 18 locations in 11 states (California, Florida, Illinois).
Frequently Asked Questions
What is clinical trial NCT02960893 about?
NCT02960893 is a clinical study titled "Trial in Adult Participants With Spinocerebellar Ataxia (SCA)". 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).
What is the current status of trial NCT02960893?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 141 participants. The study started on 2016-12-15. Estimated completion is 2024-09-20.
What conditions does trial NCT02960893 study?
This clinical trial studies the following conditions: Spinocerebellar Ataxias, Spinocerebellar Ataxia Genotype Type 1, Spinocerebellar Ataxia Genotype Type 2, Spinocerebellar Ataxia Genotype Type 3, Spinocerebellar Ataxia Genotype Type 6.
What interventions are being tested in trial NCT02960893?
The interventions under investigation include: Placebo (DRUG), Troriluzole (DRUG).
Who is sponsoring clinical trial NCT02960893?
This trial is sponsored by Biohaven Pharmaceuticals, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02960893 being conducted?
This trial has 18 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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