Study 017 trial of safety and efficacy of YKP 3089 in focal seizures published in The Lancet Neurology.- SK Life Science

SK Life Science announced The Lancet Neurology has published results from Study 017, a multicenter, double-blind, randomized, placebo-controlled, dose-response study of the safety and efficacy of YKP 3089 (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. Overall, most treatment-emergent adverse events (TEAEs) were mild or moderate in severity, and similar to those observed with other AEDs. The most common TEAEs reported were somnolence (sleepiness), dizziness, headache, fatigue and diplopia (double vision), and the incidences increased with the dosage. One serious case of drug reaction with eosinophilia and systemic symptoms (DRESS) occurred in the 200 mg cenobamate group.

See: "Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicentre, double-blind, randomised, placebo-controlled, dose-response trial" Gregory L Krauss et al. The Lancet Neurology November 13, 2019 DOI:https://doi.org/10.1016/S1474-4422(19)30399-0