Trials / Completed
CompletedNCT03605667
Study of BHV-4157 in Alzheimer's Disease
A Phase 2 Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of BHV-4157 in Patients With Mild to Moderate Alzheimer's Disease
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 350 (actual)
- Sponsor
- Biohaven Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 50 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
Preclinical models suggest that riluzole, the active metabolite of BHV-4157, may protect from AD-related pathology and cognitive dysfunction. Titrated dose of BHV-4157 to 280 mg, or placebo, were administered orally once daily. Duration of treatment is 48 weeks in double-blind phase. There is also a screening period of up to 42 days; and a 4-week post-treatment observation period. Eligible participants who completed the double-blind treatment phase had the opportunity to receive open-label troriluzole for up to 48 weeks in an open-label extension (OLE) phase.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | troriluzole | Oral BHV-4157 will be given daily for up to 48 weeks |
| DRUG | Placebo oral capsule | Oral matching placebo will be given daily for up to 48 weeks |
Timeline
- Start date
- 2018-07-31
- Primary completion
- 2020-12-15
- Completion
- 2021-12-23
- First posted
- 2018-07-30
- Last updated
- 2023-12-06
- Results posted
- 2023-12-06
Locations
44 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03605667. Inclusion in this directory is not an endorsement.