First add-on perampanel for focal-onset seizures: An open-label, prospective study

Ji Hyun Kim, Dong Wook Kim, Sang Kun Lee, Dae Won Seo, Ji Woong Lee, Hae Joon Park, Sang Ahm Lee

Research output: Contribution to journalArticle

Abstract

Objectives: This study aimed to determine the efficacy and safety of perampanel added to monotherapy in patients with focal-onset seizures, with or without secondarily generalized tonic-clonic seizures. Materials & Methods: In this multicentre, open-label trial, enrolled patients were treated with perampanel monotherapy. During a 12-week titration period, perampanel was incrementally increased by 2 mg/d over ≥2-week intervals. Patients then entered a 24-week maintenance period. The primary objective was to investigate the 50% responder rate in total seizure frequency, with 75% and 100% responder rates as secondary objectives. Treatment-emergent adverse events (TEAEs) and adverse drug reactions were recorded. A post hoc analysis was performed to investigate the effect of titration speed and different concomitant AEDs on the efficacy and safety of perampanel. Results: Of the 85 patients analysed, seizure reductions of 50%, 75% and 100% were observed in 80.0% (95% confidence interval [CI]: 69.9-87.9), 71.8% (95% CI: 61.0-81.0) and 47.1% (95% CI: 36.1-58.2) during the maintenance period, respectively. The 50%, 75% and 100% response rates in patients with secondarily generalized tonic-clonic seizures were 87.5% (95% CI: 61.7-98.5), 87.5% (95% CI: 61.7-98.5) and 75.0% (95% CI: 47.6-92.7), respectively. The most common TEAEs were dizziness (50.0%), somnolence (9.8%) and headache (8.8%). The efficacy outcomes and safety profile of perampanel were more favourable with slow titration and relatively consistent when stratified by concomitant AEDs. Conclusions: Perampanel was effective and well tolerated as a first add-on to monotherapy in patients with focal-onset seizures, with or without secondarily generalized seizures.

Original languageEnglish
Pages (from-to)132-140
Number of pages9
JournalActa Neurologica Scandinavica
Volume141
Issue number2
DOIs
Publication statusPublished - 2020 Feb 1

Keywords

  • AMPA receptor
  • drug resistance
  • epilepsy
  • focal seizures
  • generalised tonic-clonic seizures

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

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  • Cite this

    Kim, J. H., Kim, D. W., Lee, S. K., Seo, D. W., Lee, J. W., Park, H. J., & Lee, S. A. (2020). First add-on perampanel for focal-onset seizures: An open-label, prospective study. Acta Neurologica Scandinavica, 141(2), 132-140. https://doi.org/10.1111/ane.13197