首页|Onset of efficacy and adverse events during Cenobamate titration period

Onset of efficacy and adverse events during Cenobamate titration period

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  • NSTL
  • Wiley
Objectives Cenobamate is an antiseizure medication (ASM) approved in Europe as adjunctive therapy for adults with inadequately controlled focal seizures。 This post hoc analysis reports onset of efficacy and characterizes time to onset， duration， and severity of the most common treatment‐emergent adverse events (TEAEs) during cenobamate titration。 Materials & Methods Adult patients with uncontrolled focal seizures taking 1 to 3 concomitant ASMs were randomized to receive adjunctive cenobamate or placebo (double‐blind studies C013 and C017) or cenobamate (open‐label study C021)。 Outcome assessments included efficacy (median percentage change in seizure frequency and onset [studies C013 and C017]) and safety (onset， duration， and severity of TEAEs [all studies])。 Results Onset of efficacy was observed by Weeks 1 to 4 of titration in studies C013 and C017 which used a faster titration schedule than study CO21。 In study C013， the median percentage seizure frequency reduction was 36。7% in patients receiving cenobamate versus 16。3% in those taking placebo (p?=?。002); in study C017， significant differences in seizure frequency emerged in Week 1 and continued throughout titration between all cenobamate groups and placebo (p?<?。001)。 The most commonly reported TEAEs were somnolence， dizziness， fatigue， and headache， with first onset of each reported as early as Week 1; however， the majority resolved。 Conclusions Reductions in seizure frequency occurred during titration with initial efficacy observed prior to reaching the target dose。 These reductions were regarded as clinically meaningful because they may indicate early efficacy at lower doses than previously expected and had a considerable impact on patient quality of life。 Long‐term treatment with adjunctive cenobamate was generally safe and well‐tolerated。

anticonvulsantscenobamateclinical trialdouble‐blind methoddrug therapycombinationdrug‐related side effects and adverse reactionsdrug‐resistant epilepsyseizures

Bernhard J. Steinhoff、Elinor Ben‐Menachem、Christian Brandt、Irene García Morales、William E. Rosenfeld、Estevo Santamarina、José M. Serratosa

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Department for Adults,Kork Epilepsy Center

Department of Clinical Neuroscience, Institute of Neuroscience and Physiology,University of

Department of General Epileptology, Bethel Epilepsy Centre,Mara Hospital, University Hospital for

Servicio de Neurología, Programa de Epilepsia,Hospital Ruber Internacional

Comprehensive Epilepsy Care Center for Children and Adults

Epilepsy Unit, Department of Neurology,Vall d'Hebron University Hospital

Epilepsy Unit, Department of Neurology,Fundación Jiménez Díaz

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2022

10.1111/ane.13659

Acta neurologica Scandinavica.

Acta neurologica Scandinavica.

ISSN：0001-6314
年,卷(期)：2022.146(3)
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