SK Life Science announced The Lancet Neurology has published results from a multicenter, double-blind, randomized, placebo-controlled, dose-response study of the safety and efficacy of cenobamate, an investigational anti-epileptic drug (AED), in adults with uncontrolled focal (partial-onset) seizures. The results of the study demonstrated that adjunctive treatment with cenobamate produced significant reductions in seizures compared to placebo.
Eligible patients taking 1-3 AEDs were randomized to once daily placebo or cenobamate 100 mg, 200 mg or 400 mg and treated for 18 weeks (6-week titration phase followed by a 12-week maintenance phase at the target dose). Key study findings included statistically significant greater median percent reductions in focal seizure frequency over the entire treatment period compared to baseline for the cenobamate 100 mg, 200 mg and 400 mg groups (36%, 55% and 55%, respectively) compared to the placebo group (24%). Additionally, a statistically significant greater percentage of patients achieved a 50% or greater reduction in focal seizures during the maintenance phase compared to baseline for the cenobamate 100 mg, 200 mg and 400 mg groups (40%, 56% and 64%, respectively) compared to the placebo group (25%). Furthermore, during the maintenance phase, 4%, 11% and 21% of patients treated with cenobamate 100 mg, 200 mg and 400 mg, respectively, reported no focal seizures compared with only 1% of placebo-treated patients.
“This is the first publication showing the results of a randomized, controlled clinical trial of cenobamate in adults with uncontrolled focal seizures,” said Gregory L. Krauss, MD, professor of neurology at Johns Hopkins University and lead author of the study. “The results demonstrated significant dose-related reductions in seizure frequency with cenobamate during the maintenance phase compared to placebo. Encouragingly, a high number of patients had zero seizures during the maintenance phase in the 200 mg and 400 mg groups.”