% 0期刊文章%一个Fabrizio Stocchi % Ulrich Dillmann %亚伦Ellenbogen %一个Sarita卡纳安许% %罗伯特·鲁宾斯%恩典梁% IPX066 Suneel Gupta % T相比,小说Carbidopa-Levodopa (CD-LD)延长释放配方和CD-LD-Entacapone先进(CLE)在帕金森病(ASCEND-PD试验)(S02.005) % D J神经病学2012% % P S02.005-S02.005 % V 78% N 1补充% X目的:比较疗效和安全性IPX066继续教育在先进的波动PD科目。首页背景IPX066旨在提供快速吸收和保持长期稳定的LD含量比速CD-LD。设计/方法:这是一个随机、双盲、-周期稳定先进的学科交叉研究(N = 110)。后开放剂量转换至IPX066(6周),受试者被随机分配接受IPX066紧随其后的是蜡烛,反之亦然(2周/期和1周之间的非盲IPX066期)。主要疗效终点是“——时间”在醒着的时间百分比(基本以24小时为主题日记)。结果:双盲交叉期间,IPX066演示了“导通”的比例低于蜡烛(23.98%比32.48%,p < 0.0001)。平均基线“导通”是5.88小时,剂量减少到3.72小时后转换。在双盲期间,意思是“导通”是3.82和5.22小时后IPX066和蜡烛,分别(p < 0.0001)。“准时”没有麻烦的运动障碍增加1.52和0.14小时IPX066和蜡烛,分别(p < 0.0001)。这些结果对应于84分钟不停工时间和83分钟“准时”没有麻烦与IPX066运动障碍。IPX066 UPDRS第二部分+第三得分也较低(29.3 vs 31.7, p = 0.0233)。主体的偏好的治疗是IPX066和蜡烛,52.4%和27.4%,p = 0.0008)。 Dosing frequency was 3.5 and 5.0 times/day with IPX066 and CLE, respectively. During the double-blind period, 20.2% (IPX066) and 13.6% (CLE) of subjects reported AEs; AEs reported by ≥ 2% of subjects during IPX066 were dyskinesia (4.5%), confusional state (3.4%), and insomnia (3.4%), and, during CLE, fall (2.3%). Four subjects reported six SAEs (atrial fibrillation, constipation, gastrointestinal toxicity, dehydration, hyperkalemia, sciatica), all during IPX066.Conclusions: IPX066, dosed 3.5 times/day, improved control of motor symptoms compared to CLE, dosed 5.0 times/day in PD patients with motor fluctuations. These results indicate IPX066 may be a useful treatment option in advanced PD patients.Supported by: IMPAX Pharmaceuticals, a division of Impax Laboratories, Inc., Hayward.Disclosure: Dr. Stocchi has received personal compensation for activities with TEVA, Novartis, GlaxoSmithKline, Lundbeck, Schering-Plough, IMPAX, Merck Serono, IMPAX and UCB. Dr. Stocchi has received research support from Novartis and GlaxoSmithKline. Dr. Dillmann has received personal compensation for activities with GSK and Orion. Dr. Ellenbogen has received personal compensation for activities with XenoPort, Inc., Teva Neuroscience, Boehringer Ingelheim Pharmaceuticals, Inc., Allergan, Inc., Novartis, Ipsen and GlaxoSmithKline, Inc. as a speaker and/or consultant. Dr. Hsu has received personal compensation for activities with IMPAX Labs as an employee.Dr. Hsu holds stock and/or stock options in IMPAX Labs, which sponsored research in which Dr.Hsu was involved as an investigator.Dr. Hsu holds stock and/or stock options in IMPAX Labs. Dr. Khanna has received personal compensation for activities with IMPAX Pharma as an employee. Dr. Khanna holds stock and/or stock options in IMPAX Pharma, which sponsored research in which Dr. Khanna was involved as an investigator. Dr. Rubens has received personal compensation for activities with IMPAX Pharmaceuticals as an employeeDr. Rubens holds stock and/or stock options in IMPAX Pharmaceuticals, which sponsored research in which Dr. Rubens was involved as an investigator. Dr. Liang has received personal compensation for activities with Boehringer Ingelheim, GlaxoSmithKline, Novartis, TEVA, and Chelsea. Dr. Gupta has received personal compensation for activities with Impax Labs as an employee. Dr. Gupta holds stock and/or stock options in Impax Labs, which sponsored research in which Dr. Gupta was involved as an investigator. Dr. Gupta has received research support from Impax Labs.Tuesday, April 24 2012, 13:00 pm-14:45 pm %U