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PO045 Perampanel as monotherapy in open-label extension studies
  1. Patrick Kwan1,2,
  2. Scott Mintzer3,
  3. Antonio Laurenza4,
  4. Anna Patten5,
  5. Karen Cartwright4
  1. 1University of Melbourne, Royal Melbourne Hospital, Melbourne, Australia
  2. 2The Chinese University of Hong Kong, Hong Kong, China
  3. 3Thomas Jefferson University, Philadelphia, PA, US
  4. 4Eisai Inc., Woodcliff Lake, NJ, US
  5. 5Eisai Ltd, Hatfield, Hertfordshire

Abstract

Background Perampanel, a selective, non-competitive AMPA receptor antagonist, is approved for adjunctive treatment of focal seizures, with or without secondary generalised seizures, and for primary generalised tonic-clonic seizures in patients with epilepsy aged ≥12 years.

Methods We analysed the seizure outcomes of individuals with focal seizures who discontinued all non-perampanel antiepileptic drugs (AEDs) and continued to receive perampanel (up to 12 mg/day) as monotherapy in two open-label extension (OLEx) studies: Study 307 (NCT00735397) and the Study 235 OLEx (NCT01161524).

Results Seven patients discontinued all concomitant AEDs and took perampanel as monotherapy (Study 307, n=6; Study 235 OLE, n=1; female, n=1; age range, 15–40 years) for up to 1099 days (157 weeks). Seizure data were available for six patients, of whom five had a≥90% reduction in overall seizure frequency between baseline and their last 13 week period of monotherapy (three were seizure-free). Five patients experienced treatment-emergent adverse events (TEAEs) during perampanel monotherapy; no TEAEs occurred in more than one patient. There were no deaths and only one serious TEAE (colitis), which was not considered related to perampanel treatment.

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