Article Text

PDF
054
ADJUNCTIVE PERAMPANEL RCT FOR PGTC SEIZURES
  1. Jacqueline French1,
  2. Gregory Krauss2,
  3. Robert Wechsler3,
  4. Xuefeng Wang4,
  5. Bree DiVentura5,
  6. Christian Brandt6,
  7. Eugen Trinka7,
  8. Terence O'Brien8,
  9. Antonio Laurenza9,
  10. Anna Patten10,
  11. Francesco Bibbiani9
  1. 1NYU Comprehensive Epilepsy Center, New York, USA
  2. 2Johns Hopkins University, Baltimore, Maryland, USA
  3. 3Idaho Comprehensive Epilepsy Center, Boise, Idaho, USA
  4. 4Chongqing Medical University, Chongqing, China
  5. 5The Epilepsy Study Consortium, Herndon, VA
  6. 6Bielefeld Evangelic Hospital, Bielefeld, Germany
  7. 7Paracelsus Medical University Salzburg, Salzburg, Austria
  8. 8Royal Melbourne Hospital, Melbourne, Australia
  9. 9Eisai Neuroscience Product Creation Unit, Woodcliff Lake, USA
  10. 10Eisai Neuroscience Product Creation Unit, Hatfield, UK

Abstract

We assessed efficacy and safety of perampanel (selective noncompetitive AMPA receptor antagonist) for primary generalised tonic-clonic (PGTC) seizures. Patients ≥12years with confirmed IGE; ≥3 PGTC seizures/8 weeks prior to randomization; receiving 1–3 concomitant AEDs were recruited. Trial consisted of 4–week screening; 4–8 week Baseline, 1:1 Randomization (perampanel titrated over 4 weeks to 8mg or highest tolerated dose versus placebo), 13–week Maintenance, 4–week Follow-up and Extension Phases. 164 patients were randomized; full analysis set included 81 patients each on perampanel and placebo. Median percent change in PGTC seizure frequency/28 days during Titration/Maintenance versus Baseline was –76.5% with perampanel versus –38.4% placebo; P<0.0001. 50% PGTC seizure responder rate was 64.2% with perampanel versus 39.5% placebo; P=0.0019. During Maintenance, 30.9% of perampanel patients were free of PGTC seizures versus 12.3% placebo. Treatment-emergent AEs (TEAEs) occurred in 82.7% of perampanel and 72.0% placebo patients; most common dizziness, fatigue, headache, somnolence, irritability. Serious TEAEs occurred in 6 (7.4%) perampanel and 7 (8.5%) placebo patients (one death in the perampanel group [accidental drowning; not treatment-related],one with placebo). In conclusion, adjunctive perampanel treatment up to 8mg improved seizure control in PGTC seizure patients, with almost 1/3 free of PGTC seizures during Maintenance. Perampanel was well tolerated. Study sponsor: Eisai Inc.

Statistics from Altmetric.com

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.