University of California San Diego is conducting new, Phase 2/3 national epilepsy clinical research trials, called Rise, to study BHV-7000, a novel investigational therapy, in focal epilepsy.

University of California San Diego is conducting new, Phase 2/3 national epilepsy clinical research trials, called Rise, to study BHV-7000, a novel investigational therapy, in focal epilepsy.

UC San Diego is one of more than 95 sites in the country participating in the Rise studies. 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 new treatment options.3

BHV-7000 is a novel anti-seizure investigational treatment in that it works on a 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 and may be better tolerated by people with epilepsy. In a Phase 1 study in healthy volunteers, BHV-7000 was found to be well-tolerated with 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 Taha Gholipour, MD, Study Investigator and Neurologist atUC San Diego. “The Rise clinical trials are 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 for a positive outcome of these trials and believe they represent a beacon of progress towards improving the quality of life 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

Rise Clinical Trials

The Rise 1 and 2 clinical trials 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 a placebo once daily. Participation in the Rise 1 and 2 trials will last 5.5 months with six visits and 4.5 months with five visits, respectively. The primary objective of the study is to determine the change from baseline in 28-day average seizure frequency.

For more information about the Rise clinical trial and to find a study site, visit epilepsyresearchstudy.com or call 858-657-6080.

References

  1. World Health Organization. Epilepsy. Available at https://www.who.int/news-room/fact-sheets/detail/epilepsy. Accessed June 6, 2024.
  2. Kobau R, Luncheon C, Greenlund KJ. About 1.5 million community-dwelling US adults with active epilepsy reported uncontrolled seizures in the past 12 months, and seizure control varied by annual family income-National Health Interview Survey, United States 2021 and 2022. Epilepsy Behav. 2024 May 30:157:109852.
  3. Ioannou P, Foster DL, Sander JW, et al. The burden of epilepsy and unmet need in people with focal seizures. Brain Behav. 2022 Sep; 12(9):e2589.
  4. Centers for Disease Control and Prevention (CDC). Types of Seizures. Available at https://www.cdc.gov/epilepsy/about/types-of-seizures.html. Accessed June 13, 2024.