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NCT03408080 · ClinicalTrials.gov registry record · Phase 3
Open Pilot Trial of BHV-4157
A Phase 3 study of Spinocerebellar Ataxias and Spinocerebellar Ataxia Type 6, sponsored by University of California, Los Angeles.
- Active
- Registry status
- Phase 3
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT03408080: Active Phase 3 study of Spinocerebellar Ataxias and Spinocerebellar Ataxia Type 6, sponsored by University of California, Los Angeles.
NCT03408080 is a Phase 3 study of Spinocerebellar Ataxias and Spinocerebellar Ataxia Type 6 that is active but no longer recruiting, run by University of California, Los Angeles. The registered enrollment target is 24 participants, below the 474-participant average among 5 other Spinocerebellar Ataxias trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03408080, a Phase 3 study of Spinocerebellar Ataxias and Spinocerebellar Ataxia Type 6, is active but no longer recruiting, sponsored by University of California, Los Angeles.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
24 adults, between the ages of 18 and 75 years, with cerebellar ataxia will be enrolled in a 12 week trial of BHV-4157 for treatment of ataxia. BHV-4157 is a pro-drug of riluzole (which is currently FDA-approved for ALS, Lou Gehrig's disease). There will be 5 visits to UCLA required--Screening when general and neurological examination, blood and urine testing, ECG, and questionnaires will be administered; Baseline when general and neurological examination and questionnaires will be administered and study drug dispensed; Week 4 and Week 12 when general and neurological examination, blood and urine testing, ECG, and questionnaires will be administered; 2 weeks after finishing study drug when general examination and blood testing will be completed. There is an option for a 36 week extension of the study drug trial.
Primary Outcome
The total score on the Scale for the Assessment and Rating of Ataxia (SARA) The SARA is a tool for assessing ataxia. It has eight categories with an accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia). When completing the outcome measure each category is assessed and scored accordingly. Scores for the eight items range as follows: Gait (0-8 points), Stance (0-6 points), Sitting (0-4 points) Speech disturbance (0-6 points) Finger chase (0-4 points) Nose-finger test (0-4 poi
Conditions Studied
Interventions
- DRUG BHV-4157
Study Locations (1)
California
- University of California, Los Angeles - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2017-12-15 |
| Est. Completion | 2024-12-15 |
| Phase | Phase 3 |
What the registry record for NCT03408080 still lists
NCT03408080 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 474-participant average among 5 other Spinocerebellar Ataxias trials with a reported enrollment target (95% lower).
The record links to 6 conditions, with Spinocerebellar Ataxias appearing as the primary indexed condition, and to 1 intervention - of which BHV-4157 is the first listed.
NCT03408080 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03408080 about?
NCT03408080 is a clinical study titled "Open Pilot Trial of BHV-4157". 24 adults, between the ages of 18 and 75 years, with cerebellar ataxia will be enrolled in a 12 week trial of BHV-4157 for treatment of ataxia. BHV-4157 is a pro-drug of riluzole (which is currently FDA-approved for ALS, Lou Gehrig's disease). There will be 5 visits to UCLA required--Screening when ...
What is the current status of trial NCT03408080?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 24 participants. The study started on 2017-12-15. Estimated completion is 2024-12-15.
What conditions does trial NCT03408080 study?
This clinical trial studies the following conditions: Spinocerebellar Ataxias, Spinocerebellar Ataxia Type 6, Spinocerebellar Ataxia Type 1, Spinocerebellar Ataxia Type 2, Spinocerebellar Ataxia 3.
What interventions are being tested in trial NCT03408080?
The interventions under investigation include: BHV-4157 (DRUG).
Who is sponsoring clinical trial NCT03408080?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03408080 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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