Cenobamate for Epilepsy

(CENOBITE Trial)

This trial tests a new epilepsy medication called cenobamate. Researchers aim to evaluate its effectiveness and monitor for serious side effects, such as DRESS syndrome, which can cause skin rashes and fever. Participants will receive the medication under close supervision to ensure safety. This trial may suit individuals with frequent or continuous seizures who are already undergoing EEG monitoring. As an Early Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

The trial does not specify if you need to stop your current medications, but it requires that you continue taking conventional antiseizure medication alongside the trial drug. If you are on medications affecting absorption, like phenobarbital, you may need to stop those.

Research has shown that cenobamate may effectively treat epilepsy, particularly for those who haven't succeeded with other treatments. In previous studies, most patients tolerated cenobamate well. For example, one study found that cenobamate reduced seizures without causing serious side effects. However, some patients experienced minor side effects, which are common with many medications.

A key concern with cenobamate is the potential risk of a rare but serious reaction called DRESS syndrome, which can involve a rash, fever, and organ problems. Regular check-ups during treatment help manage this risk.

Unlike the standard epilepsy treatments, which often include medications like levetiracetam, valproic acid, or lamotrigine, cenobamate stands out with its unique mechanism of action. Most treatments work by modulating neurotransmitter levels or blocking sodium channels, but cenobamate targets both sodium channels and GABA receptors, which may help stabilize brain activity more effectively. Researchers are excited because this dual action could potentially bring faster and more significant relief for patients who haven't responded well to existing therapies. Additionally, cenobamate's loading phase and short treatment duration offer a promising option for rapid intervention, a notable advantage over the typical long-term medication regimens.

Research shows that cenobamate, which participants in this trial will receive, effectively treats seizures, particularly in people with epilepsy unresponsive to other medications. In previous studies, more than 20% of participants stopped having seizures completely, and over half experienced at least a 50% reduction in seizures. Another study found that patients taking cenobamate had up to twice the reduction in seizures compared to those on a placebo. Long-term evidence supports these results, with nearly 50% of patients experiencing a significant decrease in seizures. These findings suggest that cenobamate could be a promising option for managing epilepsy.²⁶⁷⁸⁹