BHV-7000 Open-Label Extension Bipolar Mania Study
Reason given: Business Decision
Key facts
- Where
- Anaheim, Atlanta, Austin, Bellflower, Bentonville, Chicago, Culver City, Dayton, Decatur, DeSoto, Flowood, Gaithersburg, Garden Grove, Hollywood, Lemon Grove, Little Rock, Marlton, Miami, Miami Lakes, North Canton, Orange, Richardson, Riverside, Rogers, Savannah, St Louis, Staten Island, Torrance, and West Palm Beach, United StatesSee the 32 sites
- Phase
- Phase 2
Where in United States
- Advanced Research Center, Inc.Anaheim, United StatesNo longer taking part
- Atlanta Center for Medical ResearchAtlanta, United StatesNo longer taking part
- Community Clinical Research, Inc.Austin, United StatesNo longer taking part
- CIT LABellflower, United StatesNo longer taking part
- Pillar Clinical Research LLCBentonville, United StatesNo longer taking part
- Pillar Clinical ResearchChicago, United StatesNo longer taking part
- Uptown Research InstituteChicago, United StatesNo longer taking part
- ProScience Research GroupCulver City, United StatesNo longer taking part
- Midwest Clinical Research CenterDayton, United StatesNo longer taking part
- CenExel iResearch, LLCDecatur, United StatesNo longer taking part
- InSite Clinical Research, LLCDeSoto, United StatesNo longer taking part
- Precise Clinical ResearchFlowood, United StatesNo longer taking part
- CBH HealthGaithersburg, United StatesNo longer taking part
- CenExel CNSGarden Grove, United StatesNo longer taking part
- CenExel RCAHollywood, United StatesNo longer taking part
- Segal Trials - Larkin Behavioral Health Services-Inpatient & Early Phase SiteHollywood, United StatesNo longer taking part
- Synergy San DiegoLemon Grove, United StatesNo longer taking part
- WIRGLittle Rock, United StatesNo longer taking part
- Hassman Research InstituteMarlton, United StatesNo longer taking part
- LCC Medical Research InstMiami, United StatesNo longer taking part
- Floridian Neuroscience InstituteMiami Lakes, United StatesNo longer taking part
- Segal Trials - Miami Lakes Medical Research-Inpatient & Early Phase SiteMiami Lakes, United StatesNo longer taking part
- NBCRNorth Canton, United StatesNo longer taking part
- NRC Research InstituteOrange, United StatesNo longer taking part
- Pillar Clinical Research, LLCRichardson, United StatesNo longer taking part
- CIT IERiverside, United StatesNo longer taking part
- WRNRogers, United StatesNo longer taking part
- CenExel iResearch, LLCSavannah, United StatesNo longer taking part
- Arch Clinical TrialsSt Louis, United StatesNo longer taking part
- RBAStaten Island, United StatesNo longer taking part
- Cenexel CNSTorrance, United StatesNo longer taking part
- Neuroscience Research InstituteWest Palm Beach, United StatesNo longer taking part
Trial details
- Who runs it
- Biohaven Therapeutics Ltd.
- Trial code
- NCT06423794
- Record updated
- 16 December 2025
- Original description
The purpose of this study is to evaluate the long-term safety and tolerability of BHV-7000 in subjects with bipolar I disorder.Read full original descriptionShow less
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.
Inclusion: 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: 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.