Stonybrook Medicine Is Recruiting People For Epilepsy National Study

Stonybrook Medicine is Currently Recruiting People with Focal Epilepsy for National Study Evaluating an experimental treatment for Epilepsy

 

BHV-7000, a selective activator of the potassium channel in the brain, targets unmet need for better-tolerated, efficacious treatments for epilepsy

For more information about the trial and to find a study site, visit epilepsyresearchstudy.com.

 

STONYBROOK, NEW YORK—NOVEMBER  21, 2024— Stonybrook Medicine is conducting a Phase 2/3 national epilepsy clinical research trial, in order to study BHV-7000, an experimental drug, in focal epilepsy. Stonybrook Medicine is one of more than 95 sites in the US participating in the research study.

Epilepsy is one of the most common neurological diseases globally, affecting approximately 1.5 million people in the US and 50 million worldwide.1,2 Approximately 40% of people with epilepsy are drug-resistant, underscoring the significant need for additional treatment options.3  

BHV-7000 is an anti-seizure experimental  drug that works on the part of the nerve cells in the brain called potassium channels, which help balance the electrical activity in the brain. Activating potassium channels provides a therapeutic approach that is designed to stabilize overactive brain activity responsible for seizures. In a Phase 1 study of healthy volunteers, BHV-7000 was found to have minimal nervous system side effects such as sleepiness typically seen in anti-seizure medications. 

“One of the most pressing challenges we face within the realm of epilepsy treatment is drug resistance. For a significant portion of individuals diagnosed with epilepsy, available treatment options often prove inadequate in controlling their seizures and present significant side effects,” said Rebecca Spiegel, MD, neurologist and investigator in the trial. “The clinical trial is studying BHV-7000, which has been shown in early research to be successful in controlling seizures with a low incidence of side effects typically seen in traditional forms of treatment. We are hopeful regarding the outcome of this trial and believe it represents progress for those affected by epilepsy.” 

Epilepsy is a chronic brain disorder that affects people of all ages and causes recurring, unprovoked seizures and can have profound health effects.1 These include physical problems, such as fractures or bruising from injuries, and higher rates of psychological conditions, such as anxiety and depression.1 Seizures fall into two main categories: focal and generalized, depending upon where they start in the brain and how they affect the individual. Focal seizures affect up to 61% of people with epilepsy, begin on one side of the brain, and may cause changes in awareness, behavior, or sensation or abnormal movements on just one side of the body.3 Generalized seizures appear on both sides of the brain, usually cause loss of consciousness or awareness, and may cause abnormal movements on both sides of the body.4 

Clinical Trial 

The  clinical trial will evaluate the safety, efficacy, and tolerability of BHV-7000 in patients with focal onset epilepsy. The randomized, double-blind placebo-controlled Phase 2/3 study is recruiting people aged 18-75 who have been diagnosed with focal onset epilepsy for at least one year, have at least four or more observable focal seizures every 28 days, are considered to have drug resistant epilepsy, and are currently being treated with a stable dose of at least one-to-three anti-seizure medications. People enrolled in the study will take BHV-7000 or placebo once daily. Participation in the trial will last 5.5 months with six visits. The primary objective of the study is to determine the change from baseline in 28-day average seizure frequency.  

For more information about the clinical trial and to find a study site, visit epilepsyresearchstudy.com.