RT期刊文章SR电子T1辅助Perampanel治疗耐药的主要广义Tonic-Clonic (PGTC)特发性全身性癫痫患者的发作(IGE):一项双盲,随机,安慰剂对照的III期试验(S31.007)摩根富林明神经病学神经学乔FD Lippincott Williams &威尔金斯SP S31.007 VO 84 14补充A1杰奎琳法国A1格雷戈里·克劳斯A1罗伯特韦氏A1雪峰王A1清汤DiVentura A1基督教勃兰特A1尤金Trinka A1特伦斯J O ' brien A1安东尼奥Laurenza A1安娜彭定康A1 Francesco首页 Bibbiani年2015 UL //www.ez-admanager.com/content/84/14_Supplement/S31.007.abstract AB目的:评估疗效和安全性的辅助治疗耐药Perampanel PGTC IGE患者癫痫发作。背景:AMPA受体拮抗剂perampanel在40个国家批准了部分性癫痫发作的辅助治疗癫痫患者有或没有二级泛化蠅12岁(蠅18年在加拿大)。设计/方法:患者(蠅12年;确认IGE;蠅3 PGTC发作前8周随机化;1 - 3伴随抗癫痫药物)招募了16个国家的78个站点。这个试验(NCT01393743) Pre-randomization(四周筛选;4 - 8周基线),随机化(四周滴定,13周保养,四周后续),和扩展阶段。病人被随机双盲的条件下(1:1)安慰剂或perampanel 2毫克/天,在每周2 mg增量uptitrated 8毫克/天或最大耐受剂量。主要端点在PGTC发作频率变化百分比每28天(滴定和维护与基线)和50 [percnt]应答率(蠅50 [percnt]在PGTC发作频率减少维护和基线)。 Adverse events (AEs) were recorded. RESULTS: Of 164 randomized patients, 162 comprised the full analysis set (perampanel, n=81; placebo, n=81). Median percent changes in PGTC seizure frequency (-76.5[percnt] vs -38.4[percnt]; P<0.0001), 50[percnt] responder rate (64.2[percnt] vs 39.5[percnt]; P=0.0019), and tonic-clonic seizure-free rate (30.9[percnt] vs 12.3[percnt]) all favored perampanel vs placebo. In the safety set (n=163), treatment-emergent AEs occurred in 82.7[percnt] of perampanel-treated patients (vs placebo, 72.0[percnt]). The AEs most frequently reported with perampanel vs placebo were dizziness (32.1[percnt] vs 6.1[percnt]), fatigue (14.8[percnt] vs 6.1[percnt]), and headache (12.3[percnt] vs 9.8[percnt]). Six perampanel-treated (7.4[percnt]) and seven placebo-treated (8.5[percnt]) patients experienced serious AEs, including two deaths (accidental drowning [perampanel] and sudden unexpected death in epilepsy [placebo]). CONCLUSIONS: Adjunctive perampanel improved control of drug-resistant PGTC seizures in patients aged 蠅12 years with IGE. Perampanel was well tolerated, with safety profile consistent with previous observations. Study Supported by: Eisai IncDisclosure: Dr. French has received personal compensation for activities with Acorda Therapeutics, Inc., Alexza Pharmaceuticals, Biotie Therapies, GlaxoSmithKline, Impax Laboratories, Johnson & Johnson, Marinus Pharmaceuticals, Novartis, Sage Therapeutics, Sunovion, Dr. Krauss has received personal compensation for activities with Sunovian and Lundbeck Research USA, Inc. as a consultant. Dr. Krauss has received research support from Eisai Inc., UCB Pharma, Sunovian, SK Life Science Inc., Upsher-Smith, and the Nationa Dr. Wechsler has received personal compensation for activities with Cyberonics, Eisai Inc., Gerson Lehrman Group, Inc., Lundbeck Research USA, Inc., Sunovion, UCB Pharma, and Upsher-Smith Laboratories. Dr. Wang has nothing to disclose. Dr. DiVentura's employer has received research support from Acorda Therapeutics, Inc. Dr. Brandt has received personal compensation for activities with Otsuka, Eisai, and UCB Pharma as an advisory board and/or speaker. Dr. Trinka has received personal compensation for activities with Eisai Inc., EVER Neuro Pharma, Biogen Idec, Medtronic, Inc., Bial, UCB Pharma, G. L. Lannacher, and Boehringer Ingelheim Pharaceuticals, Inc. as a consultant and/or speaker. Dr. O'Brien has received personal compensation for activities with UCB Pharma and ScieGen Pharmaceuticals as a speaker. Dr. Laurenza has received personal compensation for activities with Eisai Inc. as an employee. Dr. Patten has received personal compensation for activities with Eisai Inc. as an employee. Dr. Bibbiani has received personal compensation for activities with Eisai Inc. as an employee.Wednesday, April 22 2015, 4:00 pm-5:45 pm