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NCT06419582Not yet recruiting

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
Biohaven Therapeutics Ltd.Phase 2/3ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Bipolar Disorder
Drug/Device/Intervention
BHV-7000
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Biohaven Therapeutics Ltd.
Funder
Biohaven Pharmaceuticals, Inc.
Timeline & enrollment
Phase
Phase 2/3
Start date
Jun 01, 2024
End date
Apr 01, 2025
Enrollment
256 participants
Primary outcome

Change in Young Mania Rating Scale (YMRS) total score from baseline to day 21

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.

ICD-10 classifications
Bipolar affective disorderBipolar affective disorder, unspecifiedOther bipolar affective disordersBipolar affective disorder, currently in remissionBipolar affective disorder, current episode mixed
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06419582
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06419582 through Pure Global AI's free database. This Phase 2/3 trial is sponsored by Biohaven Therapeutics Ltd. and is currently Not yet recruiting. The study focuses on Bipolar Disorder. Target enrollment is 256 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.