Efficacy and safety of perampanel monotherapy in patients with focal-onset seizures with newly diagnosed epilepsy or recurrence of epilepsy after a period of remission: The open-label Study 342 (FREEDOM Study)

Epilepsia Open
Takamichi YamamotoJi Hyun Kim

Abstract

Our study assessed perampanel monotherapy in patients (aged ≥12 years) with focal-onset seizures (FOS) with or without focal to bilateral tonic-clonic seizures (FBTCS) in Japan and South Korea. Study 342 (NCT03201900; FREEDOM) is a single-arm, open-label, Phase III study. Patients initially received perampanel in a 32-week 4-mg/d Treatment Phase (6-week Titration; 26-week Maintenance Periods). If they experienced a seizure during the 4-mg/d Maintenance Period, they could be up-titrated to 8 mg/d across an additional 30-week Treatment Phase (4-week Titration; 26-week Maintenance Periods). Primary endpoint was the seizure-freedom rate during the Maintenance Period (4 mg/d and last evaluated dose [4 or 8 mg/d]). Secondary endpoints included time to first seizure onset and to withdrawal during Maintenance. Treatment-emergent adverse events (TEAEs) were monitored. At data cutoff (February 28, 2019), 89 patients with FOS (84 [94.4%] with newly diagnosed epilepsy and 5 [5.6%] with recurrence of epilepsy after a period of remission) had received ≥1 perampanel dose; 16 patients discontinued during the 4-mg/d Titration Period, meaning 73 patients entered the 4-mg/d Maintenance Period and were included in the primary analysis set for effi...Continue Reading

References

Feb 5, 2000·The New England Journal of Medicine·P Kwan, M J Brodie
Mar 26, 2003·Seizure : the Journal of the British Epilepsy Association·Taoufik M Alsaadi, Catherine Thieman
Sep 9, 2005·Acta Neurologica Scandinavica·S ArroyoUNKNOWN EPMN-106/INT-28 Investigators
Feb 7, 2007·Neurology·M J BrodieUNKNOWN Levetiracetam Monotherapy Study Group
May 11, 2012·Neurology·M J BrodieP Kwan
Jul 31, 2012·Neurology·Jacqueline A FrenchMichael A Rogawski
Nov 20, 2015·Lancet Neurology·Scott MintzerMichel Baulac
Dec 19, 2017·Acta Neurologica Scandinavica·T NishidaS Kaneko
Dec 31, 2017·Seizure : the Journal of the British Epilepsy Association·Antonio Gil-NagelUNKNOWN Study 504 investigator group

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Clinical Trials Mentioned

NCT03201900
NCT00700310
NCT01618695

Software Mentioned

mITT
Statistical Analysis System
SAS

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