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NCT03701399 · ClinicalTrials.gov registry record · Phase 3
Troriluzole in Adult Participants With Spinocerebellar Ataxia
A Phase 3 study of Spinocerebellar Ataxias and Spinocerebellar Ataxia Type 6, sponsored by Biohaven Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 299
- Enrollment target
- 20
- Study locations
NCT03701399: Active Phase 3 study of Spinocerebellar Ataxias and Spinocerebellar Ataxia Type 6, sponsored by Biohaven Pharmaceuticals.
NCT03701399 is a Phase 3 study of Spinocerebellar Ataxias and Spinocerebellar Ataxia Type 6 that is active but no longer recruiting, run by Biohaven Pharmaceuticals. The registered enrollment target is 299 participants, below the 419-participant average among 5 other Spinocerebellar Ataxias trials with a reported enrollment target (29% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03701399, a Phase 3 study of Spinocerebellar Ataxias and Spinocerebellar Ataxia Type 6, is active but no longer recruiting, sponsored by Biohaven Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 299 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to compare the efficacy of Troriluzole (200 mg once daily) versus placebo after 48 weeks of treatment in subjects with spinocerebellar ataxia (SCA).
Primary Outcome
The f-SARA was a 4-item performance based scale: 1-gait, 2-stance, 3-sitting, 4-speech disturbance (0:normal (no impairment), 1: mildly impaired function, but no assistance required, 2: moderately impaired function, but needs assistance for certain parts of task, 3: severely impaired function to degree that assistance is needed for all parts of the task, 4: unable to perform function). Total score was derived as sum of individual items; ranged from 0 to 16. Higher score indicated worst outcome.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG troriluzole
Study Locations (20)
California
- CNS Trials - Long Beach
- UCLA - Los Angeles
- UCSF - San Francisco
Florida
- University of Florida Health - Gainesville
- Mayo Clinic Florida - Jacksonville
- University of South Florida - Tampa
Illinois
- Northwestern University - Chicago
- University of Chicago - Chicago
- Northwest Neurology, Ltd. - Rolling Meadows
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
Arizona
- Barrow Neurological Institute - Phoenix
Colorado
- University of Colorado Hospital - Aurora
Georgia
- Emory - Atlanta
Maryland
- Johns Hopkins Medicine - Lutherville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 299 participants |
| Start Date | 2019-03-08 |
| Est. Completion | 2026-06 |
| Phase | Phase 3 |
What the registry record for NCT03701399 still lists
NCT03701399 is an interventional study that assigns participants to a tested intervention. The registered 299 participants enrollment target is mid-sized for trials with a published cap, below the 419-participant average among 5 other Spinocerebellar Ataxias trials with a reported enrollment target (29% 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.
NCT03701399 names 20 study sites across 13 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT03701399 about?
NCT03701399 is a clinical study titled "Troriluzole in Adult Participants With Spinocerebellar Ataxia". The purpose of this study is to compare the efficacy of Troriluzole (200 mg once daily) versus placebo after 48 weeks of treatment in subjects with spinocerebellar ataxia (SCA).
What is the current status of trial NCT03701399?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 299 participants. The study started on 2019-03-08. Estimated completion is 2026-06.
What conditions does trial NCT03701399 study?
This clinical trial studies the following conditions: Spinocerebellar Ataxias, Spinocerebellar Ataxia Type 6, Spinocerebellar Ataxia Type 1, Spinocerebellar Ataxia Type 2, Spinocerebellar Ataxia Type 3.
What interventions are being tested in trial NCT03701399?
The interventions under investigation include: Placebo (DRUG), troriluzole (DRUG).
Who is sponsoring clinical trial NCT03701399?
This trial is sponsored by Biohaven Pharmaceuticals, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03701399 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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