Perampanel for tonic-clonic seizures in idiopathic generalized epilepsy A randomized trial
作者： Jacqueline A. French , Gregory L. Krauss , Robert T. Wechsler , Xue-Feng Wang , Bree DiVentura
DOI: 10.1212/WNL.0000000000001930
关键词: Clinical endpoint 、 Idiopathic generalized epilepsy 、 Juvenile myoclonic epilepsy 、 Anesthesia 、 Lamotrigine 、 European union 、 Epilepsy 、 Medicine 、 Perampanel 、 Placebo
摘要: Objective: To assess efficacy and safety of adjunctive perampanel in patients with drug-resistant, primary generalized tonic-clonic (PGTC) seizures idiopathic epilepsy (IGE). Methods: In this multicenter, double-blind study (ClinicalTrials.gov identifier: NCT01393743; funded by Eisai Inc.), 12 years or older PGTC IGE were randomized to placebo during a 4-week titration period (perampanel uptitrated from 2 8 mg/d, highest tolerated dose) 13-week maintenance period. The endpoint was percent change seizure frequency per 28 days (titration plus vs baseline). key secondary (primary for European Union registration) 50% responder rate (patients achieving ≥50% reduction frequency; Treatment-emergent adverse events monitored. Results: Of 164 patients, 162 comprised the full analysis set (placebo, 81; perampanel, 81). Compared placebo, conferred greater median (−38.4% −76.5%; p Conclusions: Adjunctive well improved control drug-resistant IGE. Classification evidence: This provides Class I evidence that reduces frequency, compared
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