BHV-7000 Acute Treatment of Bipolar Mania

Phase 3CompletedNCT06419582

Biohaven Therapeutics Ltd.274 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

274

Conditions

Bipolar Disorder

Interventions

BHV-7000DRUG

BHV-7000 75 mg taken once daily for 21 days

PlaceboDRUG

Matching placebo taken once daily for 21 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (32)

Outcomes

Primary Outcomes

Change in Young Mania Rating Scale (YMRS) total score from baseline to day 21

The YMRS is a clinician administered scale that consists of 11 items used to assess the subject's symptoms of mania (total scores range from 0 to 60). The higher the YMRS score, the more severe the subject's symptoms of mania.

Time frame: Baseline (day 1) to day 21

Secondary Outcomes

Change in Clinical Global Clinical Impression - Severity Scale (CGI-S) total score

This objective will be measured by the change in Clinical Global Impression of Severity (CGI-S) score from baseline (day 1) to day 21). The CGI-S is a global index of patient disease severity as rated by the clinician on a scale from 1 to 7, where 7 represents most severe patients.

Time frame: Baseline (day 1) to day 21

Percentage of participants showing treatment response

Treatment response is defined as greater than or equal to 50% reduction from baseline to day 21 on the YMRS total score. The YMRS is a clinician administered scale that consists of 11 items used to assess the subject's symptoms of mania (total scores range from 0 to 60). The higher the YMRS score, the more severe the subject's symptoms of mania.

Time frame: Baseline (day 1) to day 21

Percentage of participants showing treatment remission

Treatment remission is defined as score of less than or equal to 12 on the YMRS total score from baseline to day 21. The YMRS is a clinician administered scale that consists of 11 items used to assess the subject's symptoms of mania (total scores range from 0 to 60). The higher the YMRS score, the more severe the subject's symptoms of mania.

Time frame: Baseline (day 1) to day 21

Change in Young Mania Rating Scale (YMRS) total score from baseline to day 7

This objective will be measured by the change in YMRS total score from baseline (day 1) to day 7. The YMRS is a clinician administered scale that consists of 11 items used to assess the subject's symptoms of mania (total scores range from 0 to 60). The higher the YMRS score, the more severe the subject's symptoms of mania.

Data from ClinicalTrials.gov

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