BHV-7000 Acute Treatment of Bipolar Mania

NCT06419582 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2025-12-16

No results posted yet for this study

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

DRUG

BHV-7000

BHV-7000 75 mg taken once daily for 21 days

DRUG

Placebo

Matching placebo taken once daily for 21 days

Sponsors & Collaborators

  • Biohaven Therapeutics Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-28
Primary Completion
2025-01-15
Completion
2025-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06419582 on ClinicalTrials.gov