Long-term study assessing Safety and Tolerability of BHV-7000 (201)
Research type
Research Study
Full title
A Phase 2, Global, Multicenter, Long-term Safety Study Designed to Assess the Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Onset Epilepsy (EU CT: 2023-508813-18-00)
IRAS ID
1010242
Contact name
Meghan Lovegren
Contact email
Sponsor organisation
Biohaven Therapeutics, Ltd. c/o Biohaven Pharmaceuticals Inc. (BPI)
Clinicaltrials.gov Identifier
Research summary
Epilepsy is a neurological disease characterized by unexpected seizures. Refractory focal onset epilepsy is a type of epilepsy in which seizures start in one part of the brain and are not well-controlled despite patients taking antiseizure treatments. Several antiseizure drugs are currently available, but they do not always ensure good control of seizures and can cause many side effects. The investigational drug BHV-7000 is a small molecule that works by increasing the opening of a channel protein called Kv7.2/7.3. The Kv7.2/7.3 channel is present on the surface of brain cells and regulates the brain’s electrical activity. By increasing its opening, BHV-7000 is thought to prevent seizures. BHV-7000 is also believed to be safer and better tolerated compared to other antiseizure drugs due to its unique structure.
The proposed study is a Phase 2 study that aims to evaluate if BHV-7000 is safe to use and if it reduces seizures in adults with refractory focal epilepsy.
Approximately 660 eligible subjects will enter this study after completing the double-blind phase of either the parent studies (in the UK this is BHV7000-303).
The study will consist of a 52-week treatment phase followed by a 2-week follow-up phase involving assessments including physical exams, vital signs, ECG, blood and urine samples, questionnaires and diary review.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
24/EM/0197
Date of REC Opinion
21 Aug 2024
REC opinion
Further Information Favourable Opinion