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PERAMPANEL TREATMENT FOR GENERALISED TONIC-CLONIC SEIZURES
  1. Terence O'Brien1,
  2. Anna Patten2,
  3. Francesco Bibbiani3,
  4. Haichen Yang3,
  5. Betsy Williams3,
  6. Antonio Laurenza3
  1. 1 The Royal Melbourne Hospital, The University of Melbourne, Australia
  2. 2 Eisai Ltd, UK
  3. 3 Eisai Inc, USA

Abstract

Purpose A post hoc analysis evaluated the efficacy and tolerability of perampanel across four Phase III studies in patients with secondarily generalised (SG) or primary generalised tonic-clonic (PGTC) seizures.

Method All studies involved patients aged ≥12 years. Studies 304 (n=388) and 305 (n=386) evaluated perampanel 8 or 12 mg/day or placebo. Study 306 (n=706) evaluated perampanel 2, 4, or 8 mg/day or placebo. These studies had a 19-week double-blind phase (6-week titration; 13-week maintenance). Study 332 (n=164) evaluated perampanel up to 8 mg/day or placebo (17-week double-blind phase; 4-week titration, 13-week maintenance). Full Analysis Set (FAS) included patients who had SG or PGTC seizures and received perampanel 8 mg/day.

Results FAS included 492 patients (mean age 31.7 years). Compared with placebo, perampanel conferred a greater median percent reduction in PGTC/SG seizure frequency per 28 days (−24.6% vs. −65.5%; p<0.0001), greater 50% responder rate (37.8% vs. 61.8%; p<0.0001) and higher rate of seizure freedom from PGTC/SG (12.6% vs. 26.9%). Compared with placebo, most common adverse events with perampanel were dizziness (5.9% vs. 28.6%), somnolence (5.9% vs. 13.4%), and headache (10.6% vs. 12.2%).

Conclusion Perampanel reduced generalised tonic-clonic seizure frequency, whether primary or SG, and was well tolerated.

Funded by Eisai Inc.

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