BHV-7000 Open-Label Extension Bipolar Mania Study

NCT ID: NCT06423794

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-24

Study Completion Date

2025-04-25

Brief Summary

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The purpose of this study is to evaluate the long-term safety and tolerability of BHV-7000 in subjects with bipolar I disorder.

Detailed Description

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Conditions

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Bipolar Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BHV-7000

Group Type EXPERIMENTAL

BHV-7000

Intervention Type DRUG

BHV-7000 75 mg taken once daily

Interventions

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BHV-7000

BHV-7000 75 mg taken once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subjects must have successfully completed the parent study, BHV7000-204.
2. WOCBP must have a negative urine pregnancy test at Baseline visit.
3. WOCBP must not be breastfeeding or lactating at Baseline visit or any point in the study.

Exclusion Criteria

1. Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.
2. Subjects who, in the opinion of the Investigator, will not be able to adhere to the Schedule of Assessments and/or may have difficulties complying with the treatment regimen over an extended duration of a long-term, outpatient study.
3. Investigator deems subject at imminent risk of danger to others or themself.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biohaven Therapeutics Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pillar Clinical Research, LLC

Bentonville, Arkansas, United States

Site Status

WIRG

Little Rock, Arkansas, United States

Site Status

WRN

Rogers, Arkansas, United States

Site Status

Advanced Research Center, Inc.

Anaheim, California, United States

Site Status

CIT LA

Bellflower, California, United States

Site Status

ProScience Research Group

Culver City, California, United States

Site Status

Cenexel CNS

Garden Grove, California, United States

Site Status

Synergy San Diego

Lemon Grove, California, United States

Site Status

NRC Research Institute

Orange, California, United States

Site Status

CIT IE

Riverside, California, United States

Site Status

Cenexel CNS

Torrance, California, United States

Site Status

Segal Trials - Larkin Behavioral Health Services-Inpatient & Early Phase Site

Hollywood, Florida, United States

Site Status

Cenexel - RCA

Hollywood, Florida, United States

Site Status

LCC Medical Research Inst

Miami, Florida, United States

Site Status

Floridian Neuroscience Institute

Miami Lakes, Florida, United States

Site Status

Segal Trials - Miami Lakes Medical Research-Inpatient & Early Phase Site

Miami Lakes, Florida, United States

Site Status

Neuroscience Research Institute

West Palm Beach, Florida, United States

Site Status

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Site Status

CenExel iResearch, LLC

Decatur, Georgia, United States

Site Status

CenExel iResearch, LLC

Savannah, Georgia, United States

Site Status

Uptown Research Institute

Chicago, Illinois, United States

Site Status

Pillar Clinical Research

Chicago, Illinois, United States

Site Status

CBH Health

Gaithersburg, Maryland, United States

Site Status

Precise Clinical Research

Flowood, Mississippi, United States

Site Status

Arch Clinical Trials

St Louis, Missouri, United States

Site Status

Hassman Research Institute

Marlton, New Jersey, United States

Site Status

RBA

Staten Island, New York, United States

Site Status

Midwest Clinical Research Center

Dayton, Ohio, United States

Site Status

NBCR

North Canton, Ohio, United States

Site Status

Community Clinical Research, Inc.

Austin, Texas, United States

Site Status

InSite Clinical Research, LLC

DeSoto, Texas, United States

Site Status

Pillar Clinical Research, LLC

Richardson, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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BHV7000-202

Identifier Type: -

Identifier Source: org_study_id