Christian Brandt1, Robert T Wechsler2, Terence J O'Brien3, Anna Patten4, Manoj Malhotra5, Leock Y Ngo6, Bernhard J Steinhoff7. 1. Bethel Epilepsy Centre, Maraweg 21, 33617, Bielefeld, Germany. Electronic address: Christian.Brandt@mara.de. 2. Idaho Comprehensive Epilepsy Center, 1499 West Hays St., Boise, ID, 83702, USA. Electronic address: rtw@idahoepilepsy.com. 3. The Department of Neuroscience, The Central Clinical School, Monash University, The Alfred Centre, 99 Commercial Road, Melbourne, VIC, 3004, Australia; The Departments of Medicine, The Royal Melbourne Hospital, The University of Melbourne, Grattan St., Parkville, VIC, 3010, Australia. Electronic address: terence.obrien@monash.edu. 4. Eisai Ltd., Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, UK. Electronic address: Anna_Patten@eisai.net. 5. Eisai Inc., 100 Tice Blvd, Woodcliff Lake, NJ, 07677, USA. Electronic address: Manoj_Malhotra@eisai.com. 6. Eisai Inc., 100 Tice Blvd, Woodcliff Lake, NJ, 07677, USA. Electronic address: Stella_Ngo@eisai.com. 7. Kork Epilepsy Centre, Landstraße 1, 77694, Kehl-Kork, Germany. Electronic address: BSteinhoff@epilepsiezentrum.de.
Abstract
PURPOSE: This post hoc analysis assessed the effects of adjunctive perampanel on myoclonic and absence seizure outcomes in patients (aged ≥12 years) with idiopathic generalized epilepsy (IGE) and generalized tonic-clonic seizures during the double-blind (up to 8 mg/day) and open-label extension (OLEx; up to 12 mg/day) phases of Study 332. METHODS: Patients experiencing myoclonic and/or absence seizures during study baseline were included. Assessments for myoclonic and absence seizures included: median percent change in seizure frequency, number of seizure days and seizure-free days (all per 28 days), 50 % and 75 % responder rates, seizure-freedom rates, seizure worsening, and monitoring of treatment-emergent adverse events (TEAEs). RESULTS: During the double-blind phase, myoclonic and/or absence seizures were reported in 47/163 and 60/163 patients, respectively. Median percent reductions in seizure frequency per 28 days from study baseline were 52.5% and 24.5% (myoclonic seizures) and 7.6 % and 41.2 % (absence seizures) for placebo and perampanel, respectively; seizure-freedom rates were 13.0 % and 16.7 % (myoclonic seizures) and 12.1 % and 22.2 % (absence seizures), respectively. During the OLEx phase, 46/138 and 52/138 patients experienced myoclonic and/or absence seizures, respectively. Responses during the double-blind phase were maintained during long-term (>104 weeks) adjunctive perampanel treatment. The frequency/type of TEAEs was consistent with the known safety profile of perampanel. CONCLUSION: In this post hoc analysis, adjunctive perampanel was not associated with any overall worsening of absence seizures. Further research is needed to investigate the effect of adjunctive perampanel in IGE patients with myoclonic and/or absence seizures.
PURPOSE: This post hoc analysis assessed the effects of adjunctive perampanel on myoclonic and absence seizure outcomes in patients (aged ≥12 years) with idiopathic generalized epilepsy (IGE) and generalized tonic-clonic seizures during the double-blind (up to 8 mg/day) and open-label extension (OLEx; up to 12 mg/day) phases of Study 332. METHODS: Patients experiencing myoclonic and/or absence seizures during study baseline were included. Assessments for myoclonic and absence seizures included: median percent change in seizure frequency, number of seizure days and seizure-free days (all per 28 days), 50 % and 75 % responder rates, seizure-freedom rates, seizure worsening, and monitoring of treatment-emergent adverse events (TEAEs). RESULTS: During the double-blind phase, myoclonic and/or absence seizures were reported in 47/163 and 60/163 patients, respectively. Median percent reductions in seizure frequency per 28 days from study baseline were 52.5% and 24.5% (myoclonic seizures) and 7.6 % and 41.2 % (absence seizures) for placebo and perampanel, respectively; seizure-freedom rates were 13.0 % and 16.7 % (myoclonic seizures) and 12.1 % and 22.2 % (absence seizures), respectively. During the OLEx phase, 46/138 and 52/138 patients experienced myoclonic and/or absence seizures, respectively. Responses during the double-blind phase were maintained during long-term (>104 weeks) adjunctive perampanel treatment. The frequency/type of TEAEs was consistent with the known safety profile of perampanel. CONCLUSION: In this post hoc analysis, adjunctive perampanel was not associated with any overall worsening of absence seizures. Further research is needed to investigate the effect of adjunctive perampanel in IGE patients with myoclonic and/or absence seizures.
Authors: Giovanni Assenza; Cristofaro Nocerino; Mario Tombini; Giancarlo Di Gennaro; Alfredo D'Aniello; Alberto Verrotti; Alfonso Marrelli; Lorenzo Ricci; Jacopo Lanzone; Vincenzo Di Lazzaro; Leonilda Bilo; Antonietta Coppola Journal: Front Neurol Date: 2021-03-24 Impact factor: 4.003
Authors: Jacqueline A French; Robert T Wechsler; Eugen Trinka; Christian Brandt; Terence J O'Brien; Anna Patten; Alejandro Salah; Manoj Malhotra Journal: Epilepsia Open Date: 2022-05-06