Bipolar DisorderPhase 2NCT06423794
BHV-7000 Open-Label Extension Bipolar Mania Study
A Phase 2 study testing BHV-7000 in people with Bipolar Disorder, run by Biohaven Therapeutics Ltd. at 32 sites in United States.
Trial summary
The purpose of this study is to evaluate the long-term safety and tolerability of BHV-7000 in subjects with bipolar I disorder. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- BHV-7000
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 32 sitesUnited States
- Study dates
- 24 Jun 2024to 25 Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have successfully completed the parent study, BHV7000-204.
- WOCBP must have a negative urine pregnancy test at Baseline visit.
- WOCBP must not be breastfeeding or lactating at Baseline visit or any point in the study.
Who cannot join
- Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.
- 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.
- Investigator deems subject at imminent risk of danger to others or themself.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Advanced Research Center, Inc.
Anaheim, California, 92805
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Community Clinical Research, Inc.
Austin, Texas, 78754
CIT LA
Bellflower, California, 90706
Pillar Clinical Research, LLC
Bentonville, Arkansas, 72712
Uptown Research Institute
Chicago, Illinois, 60640
Pillar Clinical Research
Chicago, Illinois, 60641
ProScience Research Group
Culver City, California, 90230
Midwest Clinical Research Center
Dayton, Ohio, 45417
CenExel iResearch, LLC
Decatur, Georgia, 30030
InSite Clinical Research, LLC
DeSoto, Texas, 75115
Precise Clinical Research
Flowood, Mississippi, 39232
CBH Health
Gaithersburg, Maryland, 20877
Cenexel CNS
Garden Grove, California, 92845
Segal Trials - Larkin Behavioral Health Services-Inpatient & Early Phase Site
Hollywood, Florida, 33021
Cenexel - RCA
Hollywood, Florida, 33024
Synergy San Diego
Lemon Grove, California, 91945
WIRG
Little Rock, Arkansas, 72211
Hassman Research Institute
Marlton, New Jersey, 08053
LCC Medical Research Inst
Miami, Florida, 33126
Floridian Neuroscience Institute
Miami Lakes, Florida, 33016
Segal Trials - Miami Lakes Medical Research-Inpatient & Early Phase Site
Miami Lakes, Florida, 33016
NBCR
North Canton, Ohio, 44720
NRC Research Institute
Orange, California, 92868
Pillar Clinical Research, LLC
Richardson, Texas, 75080
CIT IE
Riverside, California, 92506
WRN
Rogers, Arkansas, 72758
CenExel iResearch, LLC
Savannah, Georgia, 31405
Arch Clinical Trials
St Louis, Missouri, 63141
RBA
Staten Island, New York, 10329
Cenexel CNS
Torrance, California, 90504
Neuroscience Research Institute
West Palm Beach, Florida, 33407
About this study
Official title: 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.
- Conditions
- Bipolar Disorder
- Being tested
- BHV-7000
- Keywords
- bipolar, mania, manic episode, manic state, bipolar disorder type 1, manic depressive, manic bipolar, mixed features, mixed episode, mixed mania, bipolar episode, bipolar disorder
- Medical subject headings
- Bipolar Disorder, Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BHV-7000Drug
BHV-7000 75 mg taken once daily
| Study group | Role | What they receive |
|---|---|---|
| BHV-7000 | Experimental | Not described Receives: Drug: BHV-7000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinically Significant Laboratory Abnormalities
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.
Measured: Up to 52 weeks
Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication
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).
Measured: Up to 52 weeks
Number of Participants With Vital Sign Abnormalities
Measured: Up to 52 weeks
Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start24 Jun 2024
- Primary completion25 Apr 2025
- Study completion25 Apr 2025
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biohaven Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423794
- Sponsor's protocol ID
- BHV7000-202
- Status last verified
- Dec 2025
- First submitted
- 16 May 2024
- Last updated
- 16 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06423794
- Acronym / sponsor ID
- BHV7000-202
- Conditions
- Bipolar Disorder
- Keywords
- bipolar, mania, manic episode, manic state, bipolar disorder type 1, manic depressive, manic bipolar, mixed features
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Biohaven Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the long-term safety and tolerability of BHV-7000 in subjects with bipolar I disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BHV-7000 | Experimental | Drug: BHV-7000 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must have successfully completed the parent study, BHV7000-204.
- WOCBP must have a negative urine pregnancy test at Baseline visit.
- WOCBP must not be breastfeeding or lactating at Baseline visit or any point in the study.
Key exclusion criteria (3 listed)
- Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.
- 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.
- Investigator deems subject at imminent risk of danger to others or themself.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BHV-7000BHV-7000 75 mg taken once daily | Drug | BHV-7000 |
Primary outcome
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.
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).
Number of Participants With Vital Sign Abnormalities
Time frame: Up to 52 weeks
Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation
Time frame: Up to 52 weeks
Results and safety
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BHV-7000 in people with Bipolar Disorder, run by Biohaven Therapeutics Ltd. at 32 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Clinically Significant Laboratory Abnormalities (time frame: Up to 52 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.