@article {WechslerP5.233作者={罗伯特T韦氏和杰奎琳法国和尤金Trinka和基督教勃兰特和特伦斯O {\ textquoteright} Brien Francesco Bibbiani和安娜彭定康安东尼奥Laurenza}, title ={辅助perampanel的长期安全性和有效性的结果: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)},体积={88}={16}补充数量,elocation-id = {P5.233} ={2017},出版商= {Wolters Kluwer健康,公司代表美国神经病学学会},文摘={目的:探讨长期安全性和有效性的辅助perampanel OLEx第三阶段的研究。首页背景: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发作癫痫患者年龄> = 12年。在一个随机、双盲、安慰剂对照III期研究(研究332;法国et al .神经学20首页15;85:950 {\ textendash} 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50 \ %的变化相对于基线应答率。结果:模态perampanel剂量6 {\ textendash} 8毫克/天(n = 93);10 {\ textendash} 12毫克/天(n = 34);2 {\ textendash} 4毫克/天(n = 11)。 The mean (standard deviation) duration of perampanel exposure was 83.9 (38.4) weeks (range, 2.4{\textendash}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 {\"o}sterreichischer Fond with Wissenschaftsf{\"o}derung, 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{\textquoteright}Brien has received personal compensation for activities with UCB Pharma and Eisai Inc. Dr. O{\textquoteright}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.}, issn = {0028-3878}, URL = {//www.ez-admanager.com/content/88/16_Supplement/P5.233}, eprint = {//www.ez-admanager.com/content}, journal = {Neurology} }