Long-term Safety and Tolerability of BHV-7000
About
Brief Summary
A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset epilepsy
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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
Join this Trial
Enrolling by Invitation
These studies are not open to everyone who meets the eligibility criteria, but
only to people in that particular population, who are specifically invited to participate.
Study Stats
Protocol No.
24-5293
Category
Brain/Neurological Diseases
Principal Investigator
Contact
Location
- UCLA Westwood