Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
274 participants
INTERVENTIONAL
2024-05-28
2025-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BHV-7000
BHV-7000
BHV-7000 75 mg taken once daily for 21 days
Placebo
Placebo
Matching placebo taken once daily for 21 days
Interventions
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BHV-7000
BHV-7000 75 mg taken once daily for 21 days
Placebo
Matching placebo taken once daily for 21 days
Eligibility Criteria
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Inclusion Criteria
2. Male and female participants 18 years to 75 years of age at the time of the screening visit.
3. Body Mass Index (BMI) must be ≥ 18 kg/m2 and ≤ 35 kg/m2.
4. Meets DSM-5 criteria for bipolar disorder type I, with or without mixed features, as confirmed by MINI interview with at least one well- defined prior mood episode (in addition to the current episode). The most recent prior manic episode must have occurred in the last 2 years.
5. Episode of mania must not exceed 12 weeks in duration.
6. Participants must be able and willing to discontinue all other psychotropic medications during the Screening Phase (e.g., antidepressant, antimanic, antipsychotic medications).
Exclusion Criteria
2. Participants with a confirmed lifetime history of schizophrenia, psychotic disorders, dementia, delirium, amnesia, neurodegenerative disease, traumatic brain injury with clinically significant sequalae, seizure disorder, or other neurocognitive disorder. Previous diagnosis of psychotic spectrum disorders are allowable if the Investigator deems the diagnosis to be describing symptoms related to bipolar disorder.
3. Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.
18 Years
75 Years
ALL
No
Sponsors
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Biohaven Therapeutics Ltd.
INDUSTRY
Responsible Party
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Locations
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Pillar Clinical Research, LLC
Bentonville, Arkansas, 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
Garden Grove, California, United States
Synergy San Diego
Lemon Grove, California, United States
NRC Research Institute
Orange, California, United States
CIT IE
Riverside, California, United States
Cenexel CNS
Torrance, California, United States
Segal Trials - Larkin Behavioral Health Services-Inpatient & Early Phase Site
Hollywood, Florida, United States
Cenexel - RCA
Hollywood, Florida, United States
LCC Medical Research Inst
Miami, Florida, United States
Floridian Neuroscience Institute
Miami Lakes, Florida, United States
Segal Trials - Miami Lakes Medical Research-Inpatient & Early Phase Site
Miami Lakes, Florida, United States
Neuroscience Research Institute
West Palm Beach, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
CenExel iResearch, LLC
Decatur, Georgia, United States
CenExel iResearch, LLC
Savannah, Georgia, United States
Uptown Research Institute
Chicago, Illinois, United States
Pillar Clinical Research
Chicago, Illinois, United States
CBH Health
Gaithersburg, Maryland, United States
Precise Clinical Research
Flowood, Mississippi, United States
Arch Clinical Trials
St Louis, Missouri, United States
Hassman Research Institute
Marlton, New Jersey, United States
RBA
Staten Island, New York, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
NBCR
North Canton, Ohio, United States
Community Clinical Research, Inc.
Austin, Texas, United States
InSite Clinical Research, LLC
DeSoto, Texas, United States
Pillar Clinical Research, LLC
Richardson, Texas, United States
Countries
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Other Identifiers
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BHV7000-204
Identifier Type: -
Identifier Source: org_study_id