PT -期刊文章盟-乔纳森·哈尔福德盟-埃里克·马什AU -玛丽亚Mazurkiewicz-Beldzinska盟Boudewjin射击AU -丹尼尔Checketts AU -克莱尔·罗伯茨AU -伊丽莎白蒂埃尔TI -大麻二酚的长期安全性和有效性(CBD)在Lennox-Gastaut综合症患者(LGS):开放的扩展试验结果(GWPCARE5) (P1.264) DP - 2018年4月10 TA -神经病学PG - P1.264 VI - 90 IP - 15补充4099 - //www.ez-admanager.com/content/90/15_Supplement/P1.264.short 4100 - //www.ez-admanager.com/content/90/15_Supplement/P1.264.首页full所以Neurology2018 4月10;90 AB -目的:评估现有插件的长期安全性和有效性CBD LGS患者抗癫痫药物(AED)治疗。背景:CBD治疗癫痫的临床疗效和安全性与LGS尽早已经证明,双盲,随机三期试验(GWPCARE3和GWPCARE4)控制。我们提出一个指定临时开放的扩展(OLE)的分析这些试验(GWPCARE5;NCT02224573)。设计/方法:患者完成GWPCARE3或者GWPCARE4可以进入OLE他们收到了植物的医药研究制定纯化CBD(100毫克/毫升)在口腔的解决方案。主要终点是安全;二次端点drop-seizure和total-seizure频率和变化的主题/照顾者全球印象(S / CGIC)。结果:368年LGS患者完成GWPCARE3/4, OLE 366名(99%);在分析,67年(18%)已经撤回。平均年龄是16年(≥18年33%)。 Patients were taking a median of 3 concomitant AEDs. Mean modal dose during treatment was 23 mg/kg/day (min=2.5, max=30; n=364). Adverse events (AEs) occurred in 92% of patients and were considered treatment-related in 58%. Of patients reporting an AE, 82% reported it as mild or moderate. Some elevations in transaminases were reported. Serious AEs were reported in 26% of patients; 6% were considered treatment-related. There were 4 deaths; none were deemed treatment-related. When analyzed in five 12-week intervals over 60 weeks, median monthly drop and total seizures decreased (min–max) by 48%–70% (baseline=80) and 48%–62% (baseline=168), respectively. Approximately 88% of patients/caregivers reported improvement in overall condition on the S/CGIC scale at 24 and 48 weeks.Conclusions: Long-term add-on CBD treatment for LGS was generally well tolerated, with an AE profile similar to that observed in controlled trials. Sustained reductions in drop and total seizure frequency were observed with a high proportion of patients/caregivers reporting improvement in overall condition.Study Supported by: GW Research LtdDisclosure: Dr. Halford has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Brain Sentinel. Dr. Marsh has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eisai Pharma, Cydan Co. Dr. Marsh has received research support from Greenwhich Pharma, Zogenix Pharma. Dr. Mazurkiewicz-Beldzin has nothing to disclose. Dr. Gunning has nothing to disclose. Dr. Checketts has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with GW Research. Dr. Roberts has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with GW Research Ltd. Dr. Thiele has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with GW Pharma, Zogenix, Ovid. Dr. Thiele has received research support from GW Pharma, Zogenix.