Study Stopped
Business Decision
BHV-7000 Open-Label Extension Bipolar Mania Study
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
1 other identifier
interventional
94
1 country
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2024
Shorter than P25 for phase_2
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2024
CompletedFirst Posted
Study publicly available on registry
May 21, 2024
CompletedStudy Start
First participant enrolled
June 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2025
CompletedDecember 16, 2025
December 1, 2025
10 months
May 16, 2024
December 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
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).
Up to 52 weeks
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
Study Arms (1)
BHV-7000
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Pillar Clinical Research, LLC
Bentonville, Arkansas, 72712, United States
WIRG
Little Rock, Arkansas, 72211, United States
WRN
Rogers, Arkansas, 72758, United States
Advanced Research Center, Inc.
Anaheim, California, 92805, United States
CIT LA
Bellflower, California, 90706, United States
ProScience Research Group
Culver City, California, 90230, United States
Cenexel CNS
Garden Grove, California, 92845, United States
Synergy San Diego
Lemon Grove, California, 91945, United States
NRC Research Institute
Orange, California, 92868, United States
CIT IE
Riverside, California, 92506, United States
Cenexel CNS
Torrance, California, 90504, United States
Segal Trials - Larkin Behavioral Health Services-Inpatient & Early Phase Site
Hollywood, Florida, 33021, United States
Cenexel - RCA
Hollywood, Florida, 33024, United States
LCC Medical Research Inst
Miami, Florida, 33126, United States
Floridian Neuroscience Institute
Miami Lakes, Florida, 33016, United States
Segal Trials - Miami Lakes Medical Research-Inpatient & Early Phase Site
Miami Lakes, Florida, 33016, United States
Neuroscience Research Institute
West Palm Beach, Florida, 33407, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331, United States
CenExel iResearch, LLC
Decatur, Georgia, 30030, United States
CenExel iResearch, LLC
Savannah, Georgia, 31405, United States
Uptown Research Institute
Chicago, Illinois, 60640, United States
Pillar Clinical Research
Chicago, Illinois, 60641, United States
CBH Health
Gaithersburg, Maryland, 20877, United States
Precise Clinical Research
Flowood, Mississippi, 39232, United States
Arch Clinical Trials
St Louis, Missouri, 63141, United States
Hassman Research Institute
Marlton, New Jersey, 08053, United States
RBA
Staten Island, New York, 10329, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
NBCR
North Canton, Ohio, 44720, United States
Community Clinical Research, Inc.
Austin, Texas, 78754, United States
InSite Clinical Research, LLC
DeSoto, Texas, 75115, United States
Pillar Clinical Research, LLC
Richardson, Texas, 75080, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2024
First Posted
May 21, 2024
Study Start
June 24, 2024
Primary Completion
April 25, 2025
Study Completion
April 25, 2025
Last Updated
December 16, 2025
Record last verified: 2025-12