Cenobamate for Seizures

This trial tests a new medication, cenobamate, to evaluate its safety and effectiveness in treating Primary Generalized Tonic-Clonic (PGTC) seizures, which cause muscle stiffness and jerking. Participants will take either cenobamate or a placebo (a sugar pill) while continuing their usual seizure medications. Suitable candidates should have experience with PGTC seizures and have experienced at least five of these seizures in the last 12 weeks. As a Phase 3 trial, this study represents the final step before FDA approval, offering a chance to contribute to a potentially groundbreaking treatment.

No, you can continue taking your current anti-epileptic drugs (AEDs) during the trial. The protocol allows you to stay on 1 to 3 AEDs with fixed dosing regimens. However, certain medications like diazepam (except as a rescue medication) and others listed in the exclusion criteria cannot be taken. If you're on benzodiazepines, the dosage must remain unchanged throughout the study.

No, you will not have to stop taking your current anti-epileptic drugs (AEDs). The trial allows you to continue your usual AEDs while participating.

Research has shown that cenobamate is generally safe for patients. In one study, more than 60% of patients experienced a significant reduction in seizure frequency with cenobamate. This indicates the drug is effective and usually safe. Another study found that patients taking cenobamate had up to twice the reduction in seizures compared to those on a placebo. These results strongly suggest that cenobamate can be safely used, although it may have some side effects. Prospective trial participants should know that cenobamate has been tested in other studies and found to be effective and generally well-tolerated.¹²³⁴⁵

Cenobamate is unique because it works differently from most existing seizure medications. While many current options focus on altering neurotransmitter levels, cenobamate targets and modulates sodium channels and enhances GABA-A receptor currents, which could lead to better control of seizures. Researchers are excited about cenobamate because it has shown the potential for faster and more effective seizure reduction with a once-daily dosing regimen. This could mean more convenient and consistent seizure management for patients compared to some current treatments that require multiple doses throughout the day.

Research has shown that cenobamate, which participants in this trial may receive, is a promising treatment for seizures. Studies indicate that this medication has reduced seizures in about 62% of people, with some experiencing their seizures cut in half. Notably, about 21% of patients taking the highest dose became completely seizure-free. These results suggest cenobamate can be very effective, especially for those who haven't had success with other treatments.¹²⁶⁷⁸