TerminatedPhase 2

BHV-7000 Open-Label Extension Bipolar Mania Study

Stopped: Business Decision

United States94 participantsStarted 2024-06-24

Plain-language summary

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

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Clinically Significant Laboratory Abnormalities

Timeframe: 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

Timeframe: Up to 52 weeks

Number of Participants With Vital Sign Abnormalities

Timeframe: Up to 52 weeks

Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation

Timeframe: Up to 52 weeks

Trial details

NCT IDNCT06423794

SponsorBiohaven Therapeutics Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-25

View on ClinicalTrials.gov More Bipolar Disorder trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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.

What they're measuring

Number of Participants With Clinically Significant Laboratory Abnormalities

Timeframe: 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

Timeframe: Up to 52 weeks

Number of Participants With Vital Sign Abnormalities

Timeframe: Up to 52 weeks

Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation

Timeframe: Up to 52 weeks