Clinical trial NCT06419582: BHV-7000 Acute Treatment of Bipolar Mania
Official title: A Phase 2/3, Multicenter, Inpatient, Placebo-Controlled, Double-blind Trial of BHV-7000 for the Acute Treatment of Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
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
Lead sponsor: Biohaven Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-17
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether BHV-7000 is a safe and effective acute treatment for manic episodes in bipolar disorder I.


Eligibility criteria: Key Inclusion Criteria:

1. Participant must be voluntarily hospitalized for a current manic episode.
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).

Key Exclusion Criteria:

1. Rapid cycling is excluded as defined herein by subjects who have experienced ≥ 6 distinct mood episodes in a year. Consecutive mood episodes must be demarcated either by a partial or full remission of at least 2 months' duration or by a switch to an episode of opposite polarity. Each manic or mixed episode must have lasted at least 1 week, and each hypomanic episode must have lasted at least 4 days.
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.

Primary outcomes:
measure: Change in Young Mania Rating Scale (YMRS) total score from baseline to day 21
timeFrame: Baseline (day 1) to day 21
Secondary outcomes:
measure: Change in Clinical Global Clinical Impression - Severity Scale (CGI-S) total score
timeFrame: Baseline (day 1) to day 21
measure: Percentage of participants showing treatment response
timeFrame: Baseline (day 1) to day 21
measure: Percentage of participants showing treatment remission
timeFrame: Baseline (day 1) to day 21
measure: Change in Young Mania Rating Scale (YMRS) total score from baseline to day 7
timeFrame: Baseline (day 1) to day 7
measure: Change in Young Mania Rating Scale (YMRS) total score from baseline to day 4
timeFrame: Baseline (day 1) to day 4
measure: Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to day 21
timeFrame: Baseline (day 1) to day 21
measure: Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication
timeFrame: Baseline (day 1) to day 21
measure: Number of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: Baseline (day 1) to day 21
measure: Number of Participants With Vital Sign Abnormalities
timeFrame: Baseline (day 1) to day 21
measure: Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation
timeFrame: Baseline (day 1) to day 21
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: