A Phase 2 interventional study of BHV-7000 in Bipolar Disorder, sponsored by Biohaven Therapeutics Ltd.. Terminated at 32 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-16.
Sponsored by Biohaven Therapeutics Ltd. · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the long-term safety and tolerability of BHV-7000 in subjects with bipolar I disorder.
1,683 studies on the registry are indexed under Bipolar Disorder; 266 are open to participants now.
This study's enrollment of 94 is above the median of 64 across 1,279 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →Biohaven Therapeutics Ltd. is the lead sponsor of 20 studies on the registry; 9 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: BHV-7000
BHV-7000 75 mg taken once daily
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.
Time frame: 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).
Time frame: Up to 52 weeks
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
This study is terminated, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Opakalim
Biohaven Therapeutics Ltd.