A french real-world experience with cenobamate in patients with drug-resistant focal epilepsy: A retrospective observational study.

Epilepsy is a common and disabling neurological disorder. To significantly improve the quality of life of patients, the primary goal is to achieve seizure freedom. Unfortunately, 30 % of epilepsies are drug-resistant and seizure freedom is not acheived. Cenobamate is a new anti-seizure medication (ASM) used as a treatment for focal epilepsy in adults whose seizures have not been able to be controlled by two prior ASM. Two previous pivotal studies have showed an unusual seizure-free rate at 21 % and 28 %. A retrospective observational study was conducted to determine the effectiveness, safety and retention of cenobamate in 87 patients with highly focal drug-resistant epilepsy. The responder rate was 48 % with a seizure-free rate of 18 % at the last follow-up, with a mean dose of cenobamate at 216 mg. Adverse events were reported in 74 % patients, the most frequent being somnolence/fatigue and dizziness. No cases of DRESS or death were reported during the study. Cenobamate was discontinued in 34 % of patients, for a lack of efficacy despite an adequate dosage (≥ 200 mg) in 30 %, a poor tolerance in 27 %, for both insufficient efficacy and poor tolerance in 40 %, or for pregnancy plans in 3 %. Cenobamate is an effective and well-tolerated ASM in drug-resistant focal epilepsy and should be tried for highly drug-resistant epilepsy, even if many previous ASM have failed. Moreover, the impressive seizure-free rate leads to introducing cenobamate to all patients before or during the evaluation for surgical candidacy, and in any case before any resective surgery.