TY -的T1 Lacosamide转换为单一疗法治疗部分性癫痫成人:结果从一个多中心、随机、双盲、Historical-Controlled试验(P3.274) JF -神经学乔-神经学六世- 82 - 10补充SP - P3.274盟罗伯特韦氏AU -乔治·李盟杰奎琳法国非盟-特伦斯O ' brien AU - O尼尔D’cruz AU -波莱特·威廉姆斯盟梅丽莎·布洛克Y1 - 2014/04/0首页8 UR - //www.ez-admanager.com/content/82/10_Supplement/P3.274.abstract N2 -目的:评估的有效性和安全性转换Lacosamide 400毫克/天单药治疗成人患者部分性癫痫(POS)。背景:FDA接受conversion-to-monotherapy试验,使用历史试验数据作为控制,提供抗癫痫(AED)疗效的证据。pseudo-placebo的预期出口比例65.3%,预测区间的下限95%,112天的维护阶段建立了8个试验的荟萃分析的历史控制退出百分比(Epilepsia法国等,2010)。设计/方法:患者(16 - 70岁)在一个稳定剂1 - 2 aed经历蠅2≤40 POS / 28天在8周准基线随机3:1 lacosamide 400毫克/天或300毫克/天。Lacosamide滴定到随机的剂量超过3周。六周的维护阶段由基线AED撤军和10周单药治疗阶段。主要疗效变量是Kaplan-Meier-predicted比例的病人蠅1剂量的药物和维护开始撤出背景aed(全分析集(FAS))会议蠅1天5预定义的退出标准的112组400毫克/天。结果:安全设置由425名患者(n = 106, 300毫克/天;n = 319, 400毫克/天);383人构成了FAS (n = 99, 300毫克/天; n=284, 400mg/day). The Kaplan-Meier predicted exit percentage for lacosamide 400mg/day (30%; 95% CI 24.6%, 35.5%) was statistically significantly lower than the historical control exit rate. Most patients showed improvement on the Clinical Global Impression of Change (75.4% 400mg/day and 72.7% 300mg/day) and Patient Global Impression of Change (74.3% 400mg/day and 72.7% 300mg/day). The most common treatment-emergent adverse events (TEAEs) in the 400mg/day group were dizziness (26.0%), nausea (13.8%), and headache (13.2%). These TEAEs were more common during the Titration Phase than during the Monotherapy Phase. CONCLUSIONS: Conversion to lacosamide monotherapy was statistically superior to the historical control, demonstrating that lacosamide 400 mg/day was effective as monotherapy in adults with POS. Study Supported by: UCB PharmaDisclosure: Dr. Wechsler has received personal compensation for activities with USB Pharma, GlaxoSmithKline Inc., Lundbeck, Cyberonics, Eisai Inc., Gerson Lehrman Group, Jazz Pharmaceuticals, Upsher-Smith Laboratories Inc. Dr. Wechsler has received research support from UCB Pharma, Lundbeck, Eisai Inc., Vertex, Icagen, King Pharmaceuticals, Sunovion Pharmaceuticals, Upsher-Smith Laboratories Inc., Pfizer Inc., and GlaxoSmithKline Inc. Dr. Li has received personal compensation for activities with Sunovion Pharmaceuticals as an advisory board member. Dr. Li has received research support from Sunovion Pharmaceuticals, UCB Pharma, and Upsher-Smith Laboratories. Dr. French has received research support from Acorda, Biotie, Eisai Medical Research, GlaxoSmithKline, Inc., Impax, Johnson & Johnson, MAP Pharmaceuticals, Marinus, Novartis, Lundbeck, Pfizer Inc, Sepracor, Sunovion, SK Life Science, Supernus Pharmaceuticals, UCB Inc/Schwarz Pharma, Upsher Smith, and Vertex. Dr. O'Brien has nothing to disclose. Dr. D'Cruz has received personal compensation for activities with UCB Pharma as an employee. Dr. D'Cruz holds stock and/or stock options in UCB Pharma. Dr. Williams has received personal compensation for activities with UCB Pharma as an employee. Dr. Brock has received personal compensation for activities with Schwarz Biosciences.Tuesday, April 29 2014, 3:00 pm-6:30 pm ER -