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PSYCHIATRIC/BEHAVIOURAL EVENTS WITH PERAMPANEL TREATMENT FOR PGTCS
  1. Cindy Dobrinsky1,
  2. Alan Ettinger2,
  3. William Rosenfeld3,
  4. Betsy Williams1,
  5. Antonio Laurenza1,
  6. Haichen Yang1,
  7. Anna Patten4,
  8. Francesco Bibbiani1
  1. 1 Eisai Inc, USA
  2. 2 Safe Passage Neuromonitoring, USA
  3. 3 Comprehensive Epilepsy Care Center for Children and Adults, St. Louis, USA
  4. 4 Eisai Ltd, UK

Abstract

Purpose To review psychiatric and behavioural events in a study conducted to evaluate the efficacy and safety of adjunctive perampanel in patients with uncontrolled primary generalised tonic-clonic seizures (PGTCS).

Method Following baseline (4 or 8 weeks), patients aged ≥12 years were randomised to double-blind treatment with perampanel or placebo (titration 4 weeks; maintenance 13 weeks; maximum dose 8 mg). Treatment-emergent adverse events (TEAEs) were evaluated using MedDRA search terms for psychiatric disorders and MedDRA SMQs for hostility/aggression-related events.

Results In the Safety Analysis Set (perampanel n=81; placebo n=82), psychiatric TEAEs occurred in 20 (24.7%) perampanel- and 16 (19.5%) placebo-treated patients. Most TEAEs were of mild or moderate intensity. Frequency of TEAEs related to hostility/aggression was 18.5% for perampanel and 4.9% for placebo, largely due to a higher rate of irritability with perampanel (11.1%) versus placebo (2.4%). Incidences of serious adverse events and discontinuations due to TEAEs related to hostility/aggression for perampanel versus placebo were 1.2% versus 0% and 3.7% versus 1.2%, respectively.

Conclusion Consistent with results from Phase III trials in partial epilepsy, hostility/aggression-related TEAEs occurred at a higher rate in perampanel-treated patients with PGTCS than in those treated with placebo, driven mainly by irritability.

Supported by Eisai Inc.

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