萝莉社

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 GTC seizure frequency in subjects when compared to placebo (a non-active drug).

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 IGE with GTC seizures still have seizures while on ASMs. 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 for patients who have IGE with GTC seizures.

Your participation in this study is expected to last approximately 10 to 30 weeks, or about 2 to 7 months, plus another 96 weeks (about two years) if you continue to do well on the study treatment. The study consists of:
1. Screening Phase: about 3 to 6 weeks, with 1 screening visit
2. A Day 1 Visit
3. Double-blind Phase: up to 24 weeks (6 months), with up to 6 study visits
4. Open-label Extension Phase: up to 96 weeks (about two years), with up to 12 study visits
5. Follow-Up Phase: 2 weeks after the last day you take study drug, with 1 study visit

If at any point you decide you no longer want to participate in the study, you can stop.
Participation in the study includes physical and neurological exams, questionnaires and lab tests

-Be between 18 to 75 years of age

-Have been diagnosed with IGE with GTC seizures at least 6 months prior to the screening visit

-Be on a stable dose of at least 1 and up to 3 antiseizure medication(s) (ASMs) for at least 1 month prior to consent and remain stable throughout the double blind study participation. Your treatment regimen for your epilepsy can include up to 4 treatments in total, which may consist of a combination of ASM(s), diet therapy or an implanted device (vagus nerve stimulation [VNS], deep brain stimulation [DBS], or responsive neurostimulator system [RNS]). Your study doctor will help you understand what combination of treatments are allowed. Use of these epilepsy treatments should remain stable at least until the end of your participation in the double-blind portion of the study.