A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Biohaven Therapeutics Ltd.
- Study ID
- NCT06425159
- Phase
- PHASE2/PHASE3
- Status
- Terminated
Conditions
- Generalized Epilepsy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- BHV-7000 — DRUGBHV-7000 75mg. Participants will take blinded investigational product (IP) once daily
- Placebo — DRUGMatching placebo taken once daily
Study Details
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of idiopathic generalized epilepsy with generalized tonic-clonic seizures and includes an additional open-label extension (OLE) phase.
Key Dates
- Start date
- Jun 20, 2024
- Status verified
- Mar 2026
- Primary completion
- Mar 12, 2026
- Completion
- Mar 12, 2026
Study Design
- Enrollment
- 27 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: BHV-7000 75 mg
- Placebo Comparator: Placebo
Primary Outcome Measure
Time to the Second Day with a Generalized Tonic Clonic (GTC) Seizure During the 24- week Double-blind Treatment Period [ Time Frame: Baseline to Week 24 of Double-Blind Treatment Period ]