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
StatePublished - 1 Feb 2020
Externally publishedYes

Fingerprint

Seizures
Prospective Studies
Confidence Intervals
Safety
Maintenance
Dizziness
perampanel
Drug-Related Side Effects and Adverse Reactions
Headache
Therapeutics

Keywords

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

Cite this

Kim, Ji Hyun ; Kim, Dong Wook ; Lee, Sang Kun ; Seo, Dae Won ; Lee, Ji Woong ; Park, Hae Joon ; Lee, Sang Ahm. / First add-on perampanel for focal-onset seizures : An open-label, prospective study. In: Acta Neurologica Scandinavica. 2020 ; Vol. 141, No. 2. pp. 132-140.
@article{fc1b5e9db0dd4508b4fd9ef4bf163293,
title = "First add-on perampanel for focal-onset seizures: An open-label, prospective study",
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.",
keywords = "AMPA receptor, drug resistance, epilepsy, focal seizures, generalised tonic-clonic seizures",
author = "Kim, {Ji Hyun} and Kim, {Dong Wook} and Lee, {Sang Kun} and Seo, {Dae Won} and Lee, {Ji Woong} and Park, {Hae Joon} and Lee, {Sang Ahm}",
year = "2020",
month = "2",
day = "1",
doi = "10.1111/ane.13197",
language = "English",
volume = "141",
pages = "132--140",
journal = "Acta Neurologica Scandinavica",
issn = "0001-6314",
publisher = "Wiley-Blackwell Publishing Ltd",
number = "2",

}

First add-on perampanel for focal-onset seizures : An open-label, prospective study. / Kim, Ji Hyun; Kim, Dong Wook; Lee, Sang Kun; Seo, Dae Won; Lee, Ji Woong; Park, Hae Joon; Lee, Sang Ahm.

In: Acta Neurologica Scandinavica, Vol. 141, No. 2, 01.02.2020, p. 132-140.

Research output: Contribution to journalArticle

TY - JOUR

T1 - First add-on perampanel for focal-onset seizures

T2 - An open-label, prospective study

AU - Kim, Ji Hyun

AU - Kim, Dong Wook

AU - Lee, Sang Kun

AU - Seo, Dae Won

AU - Lee, Ji Woong

AU - Park, Hae Joon

AU - Lee, Sang Ahm

PY - 2020/2/1

Y1 - 2020/2/1

N2 - 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.

AB - 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.

KW - AMPA receptor

KW - drug resistance

KW - epilepsy

KW - focal seizures

KW - generalised tonic-clonic seizures

UR - http://www.scopus.com/inward/record.url?scp=85076146471&partnerID=8YFLogxK

U2 - 10.1111/ane.13197

DO - 10.1111/ane.13197

M3 - Article

C2 - 31745975

AN - SCOPUS:85076146471

VL - 141

SP - 132

EP - 140

JO - Acta Neurologica Scandinavica

JF - Acta Neurologica Scandinavica

SN - 0001-6314

IS - 2

ER -