BHV-7000 Acute Treatment of Bipolar Mania

Bipolar Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06419582
• Other study ID #: BHV7000-204
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: May 28, 2024
• Est. completion date: April 2025

Study information

• Verified date: June 2024
• Source: Biohaven Pharmaceuticals, Inc.
• Contact: Chief Medical Officer
• Phone: 203-404-0410
• Email: clinicaltrials[@]biohavenpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 256
• Est. completion date: April 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• BHV-7000
BHV-7000 75 mg taken once daily for 21 days
• Placebo
Matching placebo taken once daily for 21 days

Locations

Country	Name	City	State
United States	Advanced Research Center, Inc.	Anaheim	California
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Community Clinical Research, Inc.	Austin	Texas
United States	CIT LA	Bellflower	California
United States	Pillar Clinical Research, LLC	Bentonville	Arkansas
United States	Pillar Clinical Research	Chicago	Illinois
United States	Uptown Research Institute	Chicago	Illinois
United States	ProScience Research Group	Culver City	California
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	CenExel iResearch, LLC	Decatur	Georgia
United States	InSite Clinical Research, LLC	DeSoto	Texas
United States	Precise Clinical Research	Flowood	Mississippi
United States	CBH Health	Gaithersburg	Maryland
United States	Cenexel CNS	Garden Grove	California
United States	Cenexel - RCA	Hollywood	Florida
United States	Segal Trials - Larkin Behavioral Health Services-Inpatient & Early Phase Site	Hollywood	Florida
United States	Synergy San Diego	Lemon Grove	California
United States	WIRG	Little Rock	Arkansas
United States	Hassman Research Institute	Marlton	New Jersey
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	NBCR	North Canton	Ohio
United States	NRC Research Institute	Orange	California
United States	Pillar Clinical Research, LLC	Richardson	Texas
United States	CIT IE	Riverside	California
United States	WRN	Rogers	Arkansas
United States	Arch Clinical Trials	Saint Louis	Missouri
United States	CenExel iResearch, LLC	Savannah	Georgia
United States	RBA	Staten Island	New York
United States	Cenexel CNS	Torrance	California
United States	Neuroscience Research Institute	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Biohaven Therapeutics Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (day 1) to day 21
Secondary	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 0 to 7, with 0 meaning not assessed and 7 reflecting the most severe patients.	Baseline (day 1) to day 21
Secondary	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.	Baseline (day 1) to day 7
Secondary	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).	Baseline (day 1) to day 21
Secondary	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 and 4 laboratory abnormalities.	Baseline (day 1) to day 21