New Clinical Trials for Epilepsy Treatment Show Promise
Introduction
More than 100 locations nationwide are participating in new clinical trials for a drug that shows promise for treating epileptic seizures among patients for whom other medications do not work. The drug, BHV-7000, activates potassium receptors in the brain, modulating seizures in a way that is different from commonly prescribed anti-seizure medications.
How the Drug Works
According to Dr. Taha Gholipour, a neurologist at the University of California, San Diego, BHV-7000 works by activating potassium receptors in the brain. This is different from other anti-seizure medications that act on sodium and calcium channels in neurons. "The potassium channel is not completely new or unknown in our neuroscience community — there have been many attempts in the past to study this route — but we have had no success in getting a drug that has minimal side effects and also effective seizure control," Gholipour said.
Phase 1 Trial Results
A phase 1 trial tested the drug in 58 patients, mostly white men with a median age of 40. The main side effects observed in just a handful of participants were headaches and abdominal discomfort, which resolved when they stopped taking the drug.
Phase 2 and 3 Trials
Biohaven Ltd., a Connecticut-based biopharmaceutical company, is working to enroll 390 participants for the second and third phases of a clinical trial designed to determine whether the drug can decrease the average seizure frequency in patients diagnosed with focal onset epilepsy, which causes seizures in a specific part of the brain. Participants must be aged 18 to 75 and are randomly assigned to receive one of two different dose strengths or a placebo.
Eligibility Criteria
To participate in the trial, patients must have a diagnosis of focal onset epilepsy made at least one year prior and experience four or more seizures in a 28-day period. They must also have been unsuccessfully treated with at least two anti-seizure medications and be on a stable dose of at least one and up to three anti-seizure treatments.
Conclusion
The results of the phase 1 trial are promising, and the next phases of the trial will determine whether BHV-7000 can effectively treat patients with focal onset epilepsy. The drug’s ability to modulate seizures through the potassium channel offers a new avenue for treatment, providing hope for patients who have not responded to other medications.
FAQs
Q: What is BHV-7000?
A: BHV-7000 is a drug that activates potassium receptors in the brain to modulate seizures.
Q: How does BHV-7000 work differently from other anti-seizure medications?
A: BHV-7000 works by activating potassium receptors in the brain, whereas other anti-seizure medications work on sodium and calcium channels in neurons.
Q: What were the results of the phase 1 trial?
A: The phase 1 trial showed that the main side effects observed in just a handful of participants were headaches and abdominal discomfort, which resolved when they stopped taking the drug.
Q: Who is eligible to participate in the phase 2 and 3 trials?
A: Patients diagnosed with focal onset epilepsy, aged 18 to 75, who have experienced four or more seizures in a 28-day period, have been unsuccessfully treated with at least two anti-seizure medications, and are on a stable dose of at least one and up to three anti-seizure treatments.