Focal Epilepsy
Conditions
Keywords
Focal Epilepsy, Epilepsy, Seizure, Refractory Epilepsy, Partial Epilepsy
Brief summary
A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset epilepsy
Interventions
DRUGBHV-7000
BHV-7000 50 mg. Participants will take open-label investigational product (IP) once daily
Sponsors
Biohaven Therapeutics Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Subjects who completed the double-blind phase (DBP) of prior parent study, BHV7000-302 or BHV7000-303. * (FOCBP) Females of Child Bearing Potential must have a negative urine pregnancy test at the Baseline/Day 0 visit Key
Exclusion criteria
* Any condition, such as an ongoing AE with/without sequelae, or is poorly tolerating IP in the double-blind phase of the parent study, that would interfere with the subject's ability to comply with study instructions, place the subject at unacceptable risk, and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator. * Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs | Up to 104 weeks | To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs. |
| Number of Subjects with Clinically Significant Laboratory Abnormalities | Up to 104 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. |
Countries
Argentina, Australia, Austria, Belgium, Chile, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, India, Italy, Mexico, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, South Africa, Spain, Switzerland, United Kingdom, United States
Outcome results
None listed