BHV-7000 Open-Label Extension Bipolar Mania Study

December 13, 2025 updated by: Biohaven Therapeutics Ltd.

A Phase 2, Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of BHV-7000 in Treatment of Bipolar I Disorder

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
94

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Pillar Clinical Research, LLC
      • Little Rock, Arkansas, United States, 72211
        • WIRG
      • Rogers, Arkansas, United States, 72758
        • WRN
    • California
      • Anaheim, California, United States, 92805
        • Advanced Research Center, Inc.
      • Bellflower, California, United States, 90706
        • CIT LA
      • Culver City, California, United States, 90230
        • Proscience Research Group
      • Garden Grove, California, United States, 92845
        • Cenexel CNS
      • Lemon Grove, California, United States, 91945
        • Synergy San Diego
      • Orange, California, United States, 92868
        • NRC Research Institute
      • Riverside, California, United States, 92506
        • CIT IE
      • Torrance, California, United States, 90504
        • Cenexel CNS
    • Florida
      • Hollywood, Florida, United States, 33021
        • Segal Trials - Larkin Behavioral Health Services-Inpatient & Early Phase Site
      • Hollywood, Florida, United States, 33024
        • Cenexel - RCA
      • Miami, Florida, United States, 33126
        • LCC Medical Research Inst
      • Miami Lakes, Florida, United States, 33016
        • Floridian Neuroscience Institute
      • Miami Lakes, Florida, United States, 33016
        • Segal Trials - Miami Lakes Medical Research-Inpatient & Early Phase Site
      • West Palm Beach, Florida, United States, 33407
        • Neuroscience Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Atlanta Center for Medical Research
      • Decatur, Georgia, United States, 30030
        • CenExel iResearch, LLC
      • Savannah, Georgia, United States, 31405
        • CenExel iResearch, LLC
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Uptown Research Institute
      • Chicago, Illinois, United States, 60641
        • Pillar Clinical Research
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • CBH Health
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Precise Clinical Research
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Arch Clinical Trials
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Hassman Research Institute
    • New York
      • Staten Island, New York, United States, 10329
        • RBA
    • Ohio
      • Dayton, Ohio, United States, 45417
        • Midwest Clinical Research Center
      • North Canton, Ohio, United States, 44720
        • NBCR
    • Texas
      • Austin, Texas, United States, 78754
        • Community Clinical Research, Inc.
      • DeSoto, Texas, United States, 75115
        • InSite Clinical Research, LLC
      • Richardson, Texas, United States, 75080
        • Pillar Clinical Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key 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.

Key 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BHV-7000
Drug: BHV-7000
BHV-7000 75 mg taken once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication
Time Frame: Up to 52 weeks
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with SAEs, AEs leading to discontinuation, AEs judged to be related to study medication that are observed during the Double-blind Treatment Phase (21 days).
Up to 52 weeks
Number of Participants With Clinically Significant Laboratory Abnormalities
Time Frame: Up to 52 weeks
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 or 4 laboratory abnormalities.
Up to 52 weeks
Number of Participants With Vital Sign Abnormalities
Time Frame: Up to 52 weeks
Up to 52 weeks
Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation
Time Frame: Up to 52 weeks
Up to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biohaven Therapeutics Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 24, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BHV7000-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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