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Leállítva2. fázis

BHV-7000 Open-Label Extension Bipolar Mania Study

Megadott ok: 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 és West Palm Beach, Egyesült ÁllamokSee the 32 sites
Phase
2. fázis

Where in Egyesült Államok

  • Advanced Research Center, Inc.Anaheim, Egyesült ÁllamokNo longer taking part
  • Atlanta Center for Medical ResearchAtlanta, Egyesült ÁllamokNo longer taking part
  • Community Clinical Research, Inc.Austin, Egyesült ÁllamokNo longer taking part
  • CIT LABellflower, Egyesült ÁllamokNo longer taking part
  • Pillar Clinical Research LLCBentonville, Egyesült ÁllamokNo longer taking part
  • Pillar Clinical ResearchChicago, Egyesült ÁllamokNo longer taking part
  • Uptown Research InstituteChicago, Egyesült ÁllamokNo longer taking part
  • ProScience Research GroupCulver City, Egyesült ÁllamokNo longer taking part
  • Midwest Clinical Research CenterDayton, Egyesült ÁllamokNo longer taking part
  • CenExel iResearch, LLCDecatur, Egyesült ÁllamokNo longer taking part
  • InSite Clinical Research, LLCDeSoto, Egyesült ÁllamokNo longer taking part
  • Precise Clinical ResearchFlowood, Egyesült ÁllamokNo longer taking part
  • CBH HealthGaithersburg, Egyesült ÁllamokNo longer taking part
  • CenExel CNSGarden Grove, Egyesült ÁllamokNo longer taking part
  • CenExel RCAHollywood, Egyesült ÁllamokNo longer taking part
  • Segal Trials - Larkin Behavioral Health Services-Inpatient & Early Phase SiteHollywood, Egyesült ÁllamokNo longer taking part
  • Synergy San DiegoLemon Grove, Egyesült ÁllamokNo longer taking part
  • WIRGLittle Rock, Egyesült ÁllamokNo longer taking part
  • Hassman Research InstituteMarlton, Egyesült ÁllamokNo longer taking part
  • LCC Medical Research InstMiami, Egyesült ÁllamokNo longer taking part
  • Floridian Neuroscience InstituteMiami Lakes, Egyesült ÁllamokNo longer taking part
  • Segal Trials - Miami Lakes Medical Research-Inpatient & Early Phase SiteMiami Lakes, Egyesült ÁllamokNo longer taking part
  • NBCRNorth Canton, Egyesült ÁllamokNo longer taking part
  • NRC Research InstituteOrange, Egyesült ÁllamokNo longer taking part
  • Pillar Clinical Research, LLCRichardson, Egyesült ÁllamokNo longer taking part
  • CIT IERiverside, Egyesült ÁllamokNo longer taking part
  • WRNRogers, Egyesült ÁllamokNo longer taking part
  • CenExel iResearch, LLCSavannah, Egyesült ÁllamokNo longer taking part
  • Arch Clinical TrialsSt Louis, Egyesült ÁllamokNo longer taking part
  • RBAStaten Island, Egyesült ÁllamokNo longer taking part
  • Cenexel CNSTorrance, Egyesült ÁllamokNo longer taking part
  • Neuroscience Research InstituteWest Palm Beach, Egyesült ÁllamokNo longer taking part

Trial details

Who runs it
Biohaven Therapeutics Ltd.
Trial code
NCT06423794
Record updated
2025. december 16.
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.

ClinicalTrials.gov NCT06423794