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
- TERMINATED
- Sex
- All
- Target Recruitment
- 94
- 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)
Pillar Clinical Research, LLC
🇺🇸Richardson, Texas, United States
WIRG
🇺🇸Little Rock, Arkansas, United States
WRN
🇺🇸Rogers, Arkansas, United States
Advanced Research Center, Inc.
🇺🇸Anaheim, California, United States
CIT LA
🇺🇸Bellflower, California, United States
ProScience Research Group
🇺🇸Culver City, California, United States
Cenexel CNS
🇺🇸Torrance, California, United States
Synergy San Diego
🇺🇸Lemon Grove, California, United States
NRC Research Institute
🇺🇸Orange, California, United States
CIT IE
🇺🇸Riverside, California, United States
Scroll for more (19 remaining)Pillar Clinical Research, LLC🇺🇸Richardson, Texas, United States