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.

Age range18 Years – 75 Years

SexALL

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✓. 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.

✕. 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.

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

NCT IDNCT06423794

SponsorBiohaven Therapeutics Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-25