BHV-7000 in Subjects with Refractory Focal Onset Epilepsy- RISE 3
Research type
Research Study
Full title
A Phase 2/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Onset Epilepsy
IRAS ID
1009549
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 characterised by recurrent seizures. Patients diagnosed with drug resistant epilepsy experience seizures originating in specific regions of the brain that remain poorly controlled despite treatment with existing antiseizure medications. While several antiseizure drugs are currently available, they often fail to provide adequate seizure control and can produce numerous side effects.
The investigational drug BHV-7000 is a small molecule designed to enhance the activity of a channel protein known as Kv7.2/7.3. This channel located on the surface of brain cells, plays a crucial role in regulating the brain’s electrical signals. By increasing the opening of the Kv7.2/7.3 channel, BHV-7000 aims to prevent seizures. Moreover, BHV-7000 is believed to offer a superior safety profile and improved tolerability compared to existing antiseizure medications, due to its unique molecular structure.
This study seeks to assess the efficacy of BHV-7000 in reducing seizure frequency among adults diagnosed with drug resistant epilepsy, while also evaluating its safety profile. By investigating the therapeutic potential of BHV-7000, we aim to provide valuable insights into its suitability as a treatment option.
The study will consist of the following phases:
•Screening (confirm participants are eligible to proceed to the observation phase)
•Observation phase (8 weeks: participants only take previously prescribed antiseizure drugs)
•Double-blind phase (meaning that neither the participant nor the study doctors will know which treatment they are taken). (8 weeks: participants will be divided into 3 groups and will receive either extended-release oral tablets of BHV-7000 or placebo, once a day, in addition to their previously prescribed antiseizure drugs:
- Group 1: 50 mg of BHV-7000
- Group 2: 75mg of BHV-7000
- Group 3: Placebo
•Follow-up phase (2 weeks).REC name
Wales REC 3
REC reference
24/WA/0136
Date of REC Opinion
18 Jun 2024
REC opinion
Further Information Favourable Opinion