TY - T1的长期安全性和有效性的结果辅助perampanel:一个开放的扩展(OLEx)的一项III期研究耐药患者主要广义tonic-clonic (PGTC)在特发性全身性癫痫发作(IGE) (P5.233) JF -神经学乔-神经学六世- 88 - 16补充SP - P5.233 AU -罗伯特T韦氏盟杰奎琳法国AU -尤金Trinka盟-基督教勃兰特AU -特伦斯O ' brien AU -弗朗西斯科·Bibbiani盟安娜彭定康AU -安东尼奥Laurenza Y1 - 2017/04/18 UR - http://n首页.neurology.org/content/88/16_Supplement/P5.233.abstract N2 -目的:评估长期安全性和有效性的辅助perampanel OLEx第三阶段的研究。背景:Perampanel批准用于辅助治疗部分性发作,有或没有其次广义癫痫,PGTC癫痫患者癫痫≥12岁。在一个随机、双盲、安慰剂对照III期研究(研究332;法国et al。神经病学85首页:950 2015;957),辅助perampanel演示了改进控制耐药PGTC IGE癫痫发作;在这里,我们报告的长期结果的OLEx阶段研究(NCT02307578)。140年设计/方法:符合条件的患者完成了双盲阶段,138年获得每日一次perampanel(≤12毫克/天)在OLEx(六周蒙蔽转换时期;≤136周维护)。安全评估包括监测不良事件(AEs)、中止、实验室测试和生命体征。疗效评估包括发作频率和变化50%应答率相对于基线。结果:模态perampanel剂量6 - 8毫克/天(n = 93);10 - 12毫克/天(n = 34);2 - 4毫克/天(n = 11)。 The mean (standard deviation) duration of perampanel exposure was 83.9 (38.4) weeks (range, 2.4–161.7). Sixty patients discontinued perampanel during the OLEx, most (n=41) due to reasons other than AEs or inadequate therapeutic effect. Treatment-emergent AEs affected 120 patients (87.0%); of these, 20 (14.5%) had severe AEs, 18 (13.0%) had serious AEs, and 13 (9.4%) had AEs leading to withdrawal. By the end of the Conversion Period, patients who had received placebo (n=70) or perampanel (n=68) during the Double-blind Phase achieved similar median changes in PGTC seizure frequency (−100.0% and −93.1%, respectively) and 50% responder rates (74.3% and 75.0%, respectively). Seizure control was maintained throughout the OLEx, irrespective of prior treatment during the Double-blind Phase.Conclusions: In this OLEx, long-term adjunctive perampanel (up to 142 weeks) demonstrated a favorable risk-benefit ratio in patients with IGE. Safety outcomes were consistent with previous observations.Study Supported by: Eisai Inc.Disclosure: Dr. Wechsler has received personal compensation for activities with Cyberonics, Eisai, Sunovion, Marinus, and Lundbeck. Dr. French has received personal compensation for activities with Acorda, Adamas, Alexza, Anavex, Biogen, BioPharm Solutions, Cerecor, Concert Pharmaceuticals, Convance, Eisai, Georgia Regents University, GSK, GW Pharma, Marinus, MonosolRx, Monteris, Nestle-Health Science, Neurelis, Novartis, Ovid Therapeutics Inc., Pfizer, Pfizer-Neusentis, Pronutria, Roivant, Sage, SK Life Sciences, Sunovion, Supernus, Takeda, UCB Inc., Upsher Smith, Xenon Pharmaceuticals, Zogenix, Zynerba as a consultant. Dr. Trinka has received personal compensation for activities Eisai, Ever Neuropharma, Novartis, Biogen Idec, Medtronics, Bial, GL Pharma, GlaxoSmithKline, Boehringer, Suniovion, Actavis, UCB, Gerrot-Lannach, BIAL, and Takeda. Dr. Trinka has received research support from Biogen, Merchk, UCD, European Union, FWF österreichischer Fond with Wissenschaftsföderung, bundesministerium for Wissenschaft and Forschung. Dr. Brandt has received personal compensation for activities with Eisai, UCB and Desitin as a consultant, speaker and advisory board member. Dr. O'Brien has received personal compensation for activities with UCB Pharma and Eisai Inc. Dr. O'Brien has received research support from Eisai Inc., UCB Pharma, Sanofi-Aventis Pharmaceuticals, Inc., SciGen, Marinus and UPS. Dr. Bibbiani has received personal compensation for activities with Eisai Inc. as an employee. Dr. Patten has received personal compensation for activities with Eisa Ltd as an employee. Dr. Laurenza has received personal compensation for activities with Eisai Inc. as an employee. ER -