TY -的T1 -二级筛查的患者随机Perampanel主要广义Tonic-Clonic癫痫(PGTCS)研究不包括29.9 [percnt]的符合条件的患者由于不准确的分类(P2.045) JF -神经学乔-神经学六世- 86 - 16补充SP - P2.045盟杰奎琳法国AU -布莉DiVentura AU -尤金Trinka AU -弗朗西斯科·Bibbiani盟Haichen杨Y1 - 2016/04/05 UR - htt首页p://www.ez-admanager.com/content/86/16_Supplement/P2.045.abstract N2 -目的:评估数量的屏幕故障期间由于不准确的诊断癫痫的独立审查研究财团(TESC)在一项随机,安慰剂对照研究耐药PGTCS Perampanel的特发性全身性癫痫(IGE)。背景:每一个非竞争性AMPA受体拮抗剂,通过辅助治疗部分癫痫发作有或没有其次广义癫痫发作和癫痫患者PGTCS≥12岁。设计/方法:TESC了患者信息提交的研究地点来确定所有病人的诊断。患者被排除在外,如果提交的信息不能确定一个明确的IGE诊断(例如,只有GTC发作和正常脑电图无家族病史或支持发作类型)或显示一个错误的IGE诊断(例如,缓慢的棘波,发育迟缓,发病的年龄≤1年,或有症状的原因)。病人的信息被认为是没有资格被送到了一个第二,独立TESC评论家。如果两个审稿人同意,病人是屏幕上失败了。如果他们不同意,第三个审稿人做出最后的决定。筛选结果:307名患者中,143例失败,117名患者不符合入选标准。其中70/117的病人没有TESC审查后才显示35 IGE误诊患者和35患者足够的信息来确定诊断。第三个审稿人做最后决定两次。 Ultimately, 164 patients received perampanel or placebo (1:1), highlighting that TESC review eliminated 70/234 (29.9[percnt]) patients initially considered eligible. The trial demonstrated a median percent change in PGTC seizure frequency per 28 days (Baseline to Treatment [Titration/Maintenance Periods]) of -76.5[percnt] perampanel versus -38.4[percnt] placebo; P<0.0001. Conclusions: TESC review eliminated 29.9[percnt] inappropriate patients from inclusion. This was the first PGTCS study that used external review to ensure appropriate classification of trial participants. Without such a review, the interpretability of results may be compromised. Support: Eisai Inc.Disclosure: Dr. French has received personal compensation for activities with Acorda, Anavex, Brabant Pharma, Bio-Pharm Solutions, Eisai Medical Research, Glaxo Smith-Kline, GW Pharma, Impax, Johnson and Johnson, Marinus, Neusentis, Neurelis, Novartis, Roivant, Pfize Dr. DiVentura has received personal compensation for activities with Epilepsy Study Consortium as an employee. Dr. DiVentura has received research support from Acorda, Alexza, Anavex, Biopharm Solutions, Concert, Eisai, and Georgia Regents University. Dr. Trinka has received personal compensation for activities Eisai, Ever Neuropharma, Biogen Idec, Medtronics, Bial, GL Pharma, GlaxoSmithKline, Boehringer, Suniovion, Actavis and UCB. Dr. Bibbiani has received personal compensation for activities with Eisai Inc. as an employee. Dr. Yang has received personal compensation for activities with Eisai Inc. as an employee.Sunday, April 17 2016, 8:30 am-5:30 pm ER -