TY -的T1 - IV卡马西平(卡马西平)短期口服卡马西平在成人癫痫患者的替代治疗:三期安全试验的主要结果(P3.251) JF -神经学乔-神经学六世- 82 - 10补充SP - P3.251盟Suresh Dheerendra AU -帕维尔•克莱恩盟维克多Biton AU -小林张盟映象Kalu AU -黛博拉·李盟乔纳森·首页哈尔福德Y1 - 2014/04/08 UR - //www.ez-admanager.com/content/82/10_Supplement/P3.251.abstract N2 -目的:我们评估安全/耐受性IV卡马西平的多个15分钟注入成人癫痫患者在稳定剂量口服卡马西平,注入一个,5分钟。背景:IV卡马西平,随着环糊精矩阵,。设计/方法:成人接受口服卡马西平(1200 - 2000 mg /天)进入一个开放研究。27天的稳定口服卡马西平之后7天/日前监禁IV卡马西平(没有口服卡马西平),最后,一个28天跟进去年第四剂量的卡马西平(口服卡马西平恢复)。患者符合口服卡马西平在-14天计算。监禁在第一天就开始了。患者接受口服卡马西平剂量在0天。从第四天1 - 4,卡马西平是管理的70%每日口服剂量每隔6小时。口服卡马西平恢复去年第四剂量后6小时。5天,患者出院2小时(速)或口服卡马西平re-administration后4小时(延长释放)。 RESULTS: 153 patients were screened: 108 enrolled, 105 were treated, 101 completed, and 4 withdrew. Patients underwent twelve 15-minute infusions and one 5-minute infusion. During the 15-minute IV period, 50% had 126 AEs. Two patients had SAEs (cerebral hemorrhage, convulsions), and 3 had AEs that led to withdrawal. During the 5-minute IV period, 17% of patients had 26 AEs. None were SAEs or led to withdrawal. During the post-IV period, 25% of patients had 75 AEs, 4 had 13 SAEs, and no patients withdrew because of AEs. No treatment-related significant abnormalities were observed in clinical and laboratory data or ECGs. The most common adverse events observed during the IV period were similar to those that occurred with oral CBZ (e.g., dizziness, headache, and somnolence). CONCLUSIONS: As multiple, 15-minute infusions, IV CBZ was safe and well-tolerated. As a single, 5-minute infusion, IV CBZ also appeared to be safe and well-tolerated. Study Supported by: Lundbeck LLC.Disclosure: Dr. Dheerendra has received personal compensation for activities with Lundbeck Research USA, Inc. as an employee. Dr. Klein has nothing to disclose. Dr. Biton has received personal compensation for activities with Merck & Co., Inc, Pfizer Inc, Jazz Pharmaceuticals, Upsher-Smith Pharmaceuticals, Lundbeck Research USA, Inc., Eisai Inc., Avigen, GlaxoSmithKline, Inc., Ortho-McNeil, Icagen, UCB Pharma, and Valeant Pharmaceuticals International. Dr. Bitoon has received research support from Eisai Inc., Pfizer Inc., Sunovian Inc., UCB Pharma, Upsher-Smith Pharmaceuticals, SK Life Science Inc., Vertex, Accera, and Civitas. Dr. Kalu has received personal compensation for activities with Lundbeck Research USA, Inc. Dr. Zhang has received personal compensation for activities with Lundbeck as an employee. Dr. Lee has received personal compensation for activities with Lundbeck Research USA, Inc. and the Foundation for Peripheral Neuropathy. Dr. Lee holds stock and/or stock options in Baxter, which sponsored research in which Dr. Lee was involved as an investigator. Dr. Halford has received personal compensation for activities with UCB Pharma as a speaker, and Lundbeck Research USA, Inc. as a consultant. Dr. Halford has received research support from UCB Pharma and King Pharmaceuticals.Tuesday, April 29 2014, 3:00 pm-6:30 pm ER -