Bipolar Disorder
Conditions
Keywords
bipolar, mania, manic episode, manic state, bipolar disorder type 1, manic depressive, manic bipolar, mixed features, mixed episode, mixed mania, bipolar episode, bipolar disorder
Brief summary
The purpose of this study is to evaluate the long-term safety and tolerability of BHV-7000 in subjects with bipolar I disorder.
Interventions
DRUGBHV-7000
BHV-7000 75 mg taken once daily
Sponsors
Biohaven Therapeutics Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Laboratory Abnormalities | Up to 52 weeks | 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. |
| Number of Participants With Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and AEs judged to be related to study medication | Up to 52 weeks | 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). |
| Number of Participants With Vital Sign Abnormalities | Up to 52 weeks | — |
| Number of Participants With Electrocardiogram (ECG) Abnormalities specific to QTc elevation | Up to 52 weeks | — |
Countries
United States
Outcome results
None listed