Trials / Completed
CompletedNCT06419582
BHV-7000 Acute Treatment of Bipolar Mania
A Phase 2/3, Multicenter, Inpatient, Placebo-Controlled, Double-blind Trial of BHV-7000 for the Acute Treatment of Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 274 (actual)
- Sponsor
- Biohaven Therapeutics Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether BHV-7000 is a safe and effective acute treatment for manic episodes in bipolar disorder I.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BHV-7000 | BHV-7000 75 mg taken once daily for 21 days |
| DRUG | Placebo | Matching placebo taken once daily for 21 days |
Timeline
- Start date
- 2024-05-28
- Primary completion
- 2025-01-15
- Completion
- 2025-01-30
- First posted
- 2024-05-17
- Last updated
- 2025-12-16
Locations
32 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06419582. Inclusion in this directory is not an endorsement.