Trials / Active Not Recruiting
Active Not RecruitingNCT03408080
Open Pilot Trial of BHV-4157
An Open Pilot Trial of BHV-4157 in Adult Subjects With Cerebellar Ataxia
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- University of California, Los Angeles · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Spinocerebellar Ataxias
- Spinocerebellar Ataxia Type 1
- Spinocerebellar Ataxia Type 2
- Spinocerebellar Ataxia 3
- Spinocerebellar Ataxia Type 6
- MSA-C
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BHV-4157 | BHV-4157 is a glutamate modulating drug that is being developed for eventual commercial use in the treatment of spinocerebellar ataxia (SCA). This is currently no approved medication indicated for SCA. |
Timeline
- Start date
- 2017-12-15
- Primary completion
- 2024-12-15
- Completion
- 2024-12-15
- First posted
- 2018-01-23
- Last updated
- 2024-05-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03408080. Inclusion in this directory is not an endorsement.