Clinical trial NCT06423794: BHV-7000 Open-Label Extension Bipolar Mania Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Bipolar Disorder
Keywords: bipolar
mania
manic episode
manic state
bipolar disorder type 1
manic depressive
manic bipolar
mixed features
mixed episode
mixed mania
bipolar episode
bipolar disorder
Lead sponsor: Biohaven Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-21
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

1. Subjects must have successfully completed the parent study, BHV7000-204.
2. WOCBP must have a negative urine pregnancy test at Baseline visit.
3. WOCBP must not be breastfeeding or lactating at Baseline visit or any point in the study.

Key Exclusion Criteria:

1. Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.
2. 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.
3. Investigator deems subject at imminent risk of danger to others or themself.

Primary outcomes:
measure: Number of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: Up to 52 weeks
measure: Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication
timeFrame: Up to 52 weeks
measure: Number of Participants With Vital Sign Abnormalities
timeFrame: Up to 52 weeks
measure: Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation
timeFrame: Up to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bentonville
country: United States
facility: Pillar Clinical Research, LLC
state: Arkansas
city: Little Rock
country: United States
facility: WIRG
state: Arkansas
city: Rogers
country: United States
facility: WRN
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Research Center, Inc.
state: California
city: Bellflower
country: United States
facility: CIT LA
state: California
city: Culver City
country: United States
facility: ProScience Research Group
state: California
city: Garden Grove
country: United States
facility: Cenexel CNS
state: California
city: Lemon Grove
country: United States
facility: Synergy San Diego
state: California
city: Orange
country: United States
facility: NRC Research Institute
state: California
city: Riverside
country: United States
facility: CIT IE
state: California
city: Torrance
country: United States
facility: Cenexel CNS
state: California
city: Hollywood
country: United States
facility: Segal Trials - Larkin Behavioral Health Services-Inpatient & Early Phase Site
state: Florida
city: Hollywood
country: United States
facility: Cenexel - RCA
state: Florida
city: Miami Lakes
country: United States
facility: Floridian Neuroscience Institute
state: Florida
city: Miami Lakes
country: United States
facility: Segal Trials - Miami Lakes Medical Research-Inpatient & Early Phase Site
state: Florida
city: Miami
country: United States
facility: LCC Medical Research Inst
state: Florida
city: West Palm Beach
country: United States
facility: Neuroscience Research Institute
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Decatur
country: United States
facility: CenExel iResearch, LLC
state: Georgia
city: Savannah
country: United States
facility: CenExel iResearch, LLC
state: Georgia
city: Chicago
country: United States
facility: Uptown Research Institute
state: Illinois
city: Chicago
country: United States
facility: Pillar Clinical Research
state: Illinois
city: Gaithersburg
country: United States
facility: CBH Health
state: Maryland
city: Flowood
country: United States
facility: Precise Clinical Research
state: Mississippi
city: Saint Louis
country: United States
facility: Arch Clinical Trials
state: Missouri
city: Marlton
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Staten Island
country: United States
facility: RBA
state: New York
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: North Canton
country: United States
facility: NBCR
state: Ohio
city: Austin
country: United States
facility: Community Clinical Research, Inc.
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research, LLC
state: Texas
city: Richardson
country: United States
facility: Pillar Clinical Research, LLC
state: Texas
Study officials:
References: