BHV-7000 Open-Label Extension Bipolar Mania Study
- Registration Number
- NCT06423794
- Lead Sponsor
- Biohaven Therapeutics Ltd.
- Brief Summary
The purpose of this study is to evaluate the long-term safety and tolerability of BHV-7000 in subjects with bipolar I disorder.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 200
- 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.
Key
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BHV-7000 BHV-7000 -
- Primary Outcome Measures
Name Time Method Number of Participants With Clinically Significant Laboratory Abnormalities Up to 52 weeks 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.
Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication Up to 52 weeks 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).
Number of Participants With Vital Sign Abnormalities Up to 52 weeks Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation Up to 52 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (29)
CIT IE
🇺🇸Riverside, California, United States
Uptown Research Institute
🇺🇸Chicago, Illinois, United States
Pillar Clinical Research
🇺🇸Chicago, Illinois, United States
LCC Medical Research Inst
🇺🇸Miami, Florida, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Neuroscience Research Institute
🇺🇸West Palm Beach, Florida, United States
Hassman Research Institute
🇺🇸Marlton, New Jersey, United States
CBH Health
🇺🇸Gaithersburg, Maryland, United States
RBA
🇺🇸Staten Island, New York, United States
WRN
🇺🇸Rogers, Arkansas, United States
Cenexel - RCA
🇺🇸Hollywood, Florida, United States
Synergy San Diego
🇺🇸Lemon Grove, California, United States
Pillar Clinical Research, LLC
🇺🇸Richardson, Texas, United States
WIRG
🇺🇸Little Rock, Arkansas, United States
CIT LA
🇺🇸Bellflower, California, United States
NRC Research Institute
🇺🇸Orange, California, United States
ProScience Research Group
🇺🇸Culver City, California, United States
Precise Clinical Research
🇺🇸Flowood, Mississippi, United States
Arch Clinical Trials
🇺🇸Saint Louis, Missouri, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
InSite Clinical Research, LLC
🇺🇸DeSoto, Texas, United States
Community Clinical Research, Inc.
🇺🇸Austin, Texas, United States
Segal Trials - Miami Lakes Medical Research-Inpatient & Early Phase Site
🇺🇸Miami Lakes, Florida, United States
CenExel iResearch, LLC
🇺🇸Savannah, Georgia, United States
Advanced Research Center, Inc.
🇺🇸Anaheim, California, United States
Cenexel CNS
🇺🇸Torrance, California, United States
Segal Trials - Larkin Behavioral Health Services-Inpatient & Early Phase Site
🇺🇸Hollywood, Florida, United States
NBCR
🇺🇸North Canton, Ohio, United States
Floridian Neuroscience Institute
🇺🇸Miami Lakes, Florida, United States