文摘
摘要目的:评估FT218的功效,once-nightly oxybate钠(所以)配方,在日间极度嗜睡(EDS),自我报告的睡眠质量/清新自然的睡眠,睡眠瘫痪症(SP),催眠的幻觉(HH)嗜睡症患者。
背景:Twice-nightly因此是一种有效的治疗EDS和猝倒嗜睡症患者。FT218是试验性once-nightly缓释制剂。
设计/方法:这是一个随机、双盲、安慰剂对照、多中心,与这些相应平行的组织研究嗜睡症患者≥16岁(随机n = 212)。的4-period uptitration剂量安排如下:4.5 g 1周,2周6克,7.5 g 5周,9 g 5周(总学习时间,17周)。二次端点包括埃普沃思嗜睡量表(ESS)、睡眠质量/清新自然的睡眠使用视觉模拟量表(血管),SP和HH使用睡眠症状日记(SSD)。
结果:FT218证明显著(P< 0.001)改善ESS和安慰剂在所有剂量测试:LS平均差−3.86 g(13周),9点3.16−7.5 g(第八周)和2.06−6克(周3)。FT218显著(P< 0.001)比安慰剂好剂量检测睡眠质量/清新自然的睡眠在脉管,SSD和SP (P9 = 0.037,0.021,0.039,7.5,分别为6克)。HH FT218和安慰剂相似。与FT218治疗最常见的不良反应是恶心、头晕、遗尿、头痛、食欲下降、呕吐。
结论:FT218临床上重要和有意义的结果和安慰剂剂量检测ESS,睡眠质量/清新自然的睡眠,和SP,代表进步重要的嗜睡症的症状。FT218一般耐受性良好,最常见的不良反应是众所周知且建立不良反应。
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