Abstract
PurposeTo assess how efficacy and safety outcomes were affected when cenobamate was co-administered with antiseizure medications (ASMs) that use either sodium channel blocker (SCB) or non-sodium channel blocker (non-SCB) mechanisms of action (MoAs) in patients with uncontrolled focal seizures. MethodsAn exploratory post-hoc analysis of a randomized, double-blind, placebo-controlled clinical study (YKP3089C017) was conducted. Baseline concomitant ASMs were grouped as either those that employed an SCB or non-SCB MoA. Efficacy was examined by cenobamate dose (100 mg, 200 mg, and 400 mg/day) and concomitant ASM group using responder rates (≥50%, ≥75%, ≥90% seizure reduction; 100% seizure reduction/seizure freedom) during the maintenance phase and median percentage seizure reduction during the double-blind period. Treatment-emergent adverse events (TEAEs) were examined in the double-blind period. ResultsWhen co-administered with SCBs or non-SCBs, significantly higher percentages of patients achieved ≥50%, ≥75%, and ≥90% responder rates with cenobamate 200 mg/day and/or 400 mg/day versus placebo. Additionally, significantly higher percentages of patients achieved seizure freedom with cenobamate 400 mg/day versus placebo (SCB group, 17.5% versus 1.2%; non-SCB group, 40.0% versus 0.0%). Patients receiving 200 mg/day and 400 mg/day and concomitant SCBs and all patients taking cenobamate combined with non-SCB concomitant ASMs had significantly greater median percentage reductions in focal seizure frequency versus placebo. TEAEs were similar across groups; however, dizziness was more frequently reported in the SCB group. ConclusionCenobamate is a highly effective new treatment option for patients with uncontrolled focal seizures when co-administered with SCB or non-SCB ASMs.
Highlights
Cenobamate is a new antiseizure medication (ASM) indicated for the treatment of focal onset seizures in adults [1]
To assess how efficacy and safety outcomes were affected when cenobamate was co-administered with antiseizure medications (ASMs) that use either sodium channel blocker (SCB) or non-sodium channel blocker mechanisms of action (MoAs) in patients with uncontrolled focal seizures
The percentage of patients who completed the double-blind period in the pooled-dose cenobamate and placebo groups was similar across the ASM MoAs of SCBs (80.8%; 87.8%), and non-SCBs (81.0%; 88.2%) (Table 1)
Summary
Cenobamate is a new antiseizure medication (ASM) indicated for the treatment of focal onset (partial-onset) seizures in adults [1]. The efficacy and safety of cenobamate were demonstrated in two double-blind, randomized, placebo-controlled, phase 2 clinical studies (NCT01397968; NCT01866111) in patients with uncontrolled focal seizures who were taking one to three concomitant ASMs [3,4]. In the 18-week (6-week titration plus 12-week maintenance phase) study (YKP3089C017), patients were treated with 100, 200, or 400 mg/day adjunctive cenobamate or placebo. Both clinical studies resulted in significantly greater reductions in seizure frequency, greater percentages of patients achieving responder rates of.
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