BHV-7000 Open-Label Extension Bipolar Mania Study

Bipolar Disorder Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06423794
• Other study ID #: BHV7000-202
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: April 2026

Study information

• Verified date: June 2024
• Source: Biohaven Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the long-term safety and tolerability of BHV-7000 in subjects with bipolar I disorder.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: April 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• BHV-7000
BHV-7000 75 mg taken once daily

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	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.	Up to 52 weeks
Primary	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).	Up to 52 weeks