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)

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Summary

Introduction

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.

Concomitant ASMs
Efficacy outcome
Safety outcome
Study design
Patient characteristics
Cenobamate with sodium channel blockers Among patients on concomitant SCBs in
Cenobamate with non-sodium channel blockers
Safety
Efficacy and safety in patients who previously failed ≥2 ASMs
Discussion
Limitations
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