A Phase 2/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of the BHV7000 in Subjects with Refractory Focal Onset Epilepsy

This is a research study to test a new investigational drug. An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA). The main purpose of this study is to assess whether an investigational drug called BHV-7000 (study drug) can reduce seizure frequency in patients with refractory focal epilepsy when compared to placebo.
BHV-7000 was designed to activate channels on the surface of brain cells called Kv7 channels. Kv7 channels open based on certain changes in cell voltage. They are involved in regulating brain activity or “neuroexcitability.” BHV-7000 makes Kv7 channels open more often by lowering the voltage at which they open. It also slows the deactivation of Kv7 channels. There are existing treatments for seizures called anti-seizure medications (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. This is a randomized, double-blind, placebo-controlled study. “Randomized” means that the group you will be placed in is decided by chance, similar to drawing numbers out of a hat or flipping a coin. “Double-blind” means that neither you nor the study doctor will know which study treatment group you have been placed in (i.e., if you are receiving BHV-7000 or placebo). This is done to make sure the results of the study cannot be influenced by anyone. If there is an urgent need, the study doctor can find out quickly which study drug you are receiving. A “placebo” is a “dummy pill” that contains no active ingredients.