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 Epilepsy
Brief description of study
The main purpose of this study is to understand whether BHV-7000 can help reduce the number of seizures in subjects with difficult to control or refractory focal epilepsy when compared to placebo (“dummy pill” or “inactive drug”). BHV-7000 was designed to open potassium channels called Kv7 on the surface of brain cells. Kv7 channels regulate brain activity or “neuroexcitability.” BHV-7000 makes Kv7 channels open more often and slows their deactivation.
There are existing treatments for seizures called ASMs. However, many patients with focal epilepsy still have seizures while on ASMs. This is called focal refractory epilepsy. When seizures are not controlled by medications, they can cause injury, difficulty in school or work, and loss of freedom. Even when seizures are under control, ASMs often have side effects that impact quality of life. There is an unmet need for safe and effective treatments in refractory focal epilepsy.
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