BHV-7000 Open-Label Extension Bipolar Mania Study

Phase 2TerminatedNCT06423794

Biohaven Therapeutics Ltd.94 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bipolar Disorder

Interventions

BHV-7000DRUG

BHV-7000 75 mg taken once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (32)

Outcomes

Primary Outcomes

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 or 4 laboratory abnormalities.

Time frame: Up to 52 weeks

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).

Time frame: Up to 52 weeks

Number of Participants With Vital Sign Abnormalities

Time frame: Up to 52 weeks

Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation

Time frame: Up to 52 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

...and 22 more locations