SAN DIEGO — More than 100 sites across the country are participating in recent clinical trials for a drug that shows promise for treating epileptic seizures in patients for whom other medications don't work.
The drug BHV-7000 prompts potassium receptors within the brain in a way that appears to modulate seizures, Dr. Taha Gholipour, a neurologist on the University of California, San Diego, a participant within the study and a neighborhood researcher on the study. Other commonly prescribed anti-seizure medications act on sodium and calcium channels in neurons. These routes are effective in some but not all patients.
About 40% of the estimated 1.5 million individuals with epilepsy are immune to drugs that attack the calcium and sodium pathways, meaning a 3rd pathway, via potassium, would greatly expand the choices for treating seizures.
“The potassium channel is not completely new or unknown in our neuroscience community – there have been many attempts to study this pathway in the past – but we have had no success in getting a drug that has minimal side effects and also effective seizure control,” said Gholipour. “But years of preclinical work in laboratories, in cell models, in animal models and then in early human clinical trials have shown that this drug appears to be well tolerated and effective in controlling seizures, which is exciting news.”
In a phase 1 trial, the drug was tested on 58 patients, mostly white men with a mean age of 40. It found that the fundamental unwanted effects, observed in just a handful of participants, were headaches and abdominal discomfort, which disappeared after stopping the medication.
Biohaven Ltd., a Connecticut-based biopharmaceutical company, is working to recruit 390 participants for the second and third phases of a clinical trial designed to find out whether the drug can reduce the common seizure frequency in patients diagnosed with partial-onset epilepsy Seizures may cause depression in a certain a part of the brain.
Participants have to be between 18 and 75 years old and can be randomly assigned to one in all two different dose strengths or a placebo, an inactive dose that is essential for comparison purposes. The diagnosis of focal epilepsy will need to have been made at the least one 12 months previously and participants will need to have suffered 4 or more seizures inside 28 days, have been unsuccessfully treated with at the least two anti-seizure medications, and are “on a stable” dose of at the least one and up to 3 antiepileptic drugs.”
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