MD1003效果(高剂量的生物素)在长期的视觉缺失与视神经炎多发性硬化症(毫秒):关键的随机双蒙面的安慰剂对照研究的结果(S49.005)

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目的:毫秒的结果研究报告评估MD1003超过安慰剂的疗效复发汇款或进步的MS患者视力丧失与视神经病变相关背景:MD1003(高剂量的生物素)最近在减少证明疗效进展和改善步行残疾患者的主要和次要进步多发性硬化症(MS)方法:这是一个随机、双盲、多中心、安慰剂对照(2:1)试验口服生物素300毫克/天在MS患者视力丧失和视神经病变有关。所有患者至少有一只眼睛视力ETDRS评分≤72至少6个月。我们包括患者要么视觉损失后视神经炎复发(复发,n = 62)或慢性进行性视神经炎患者(进步,n = 31)。治疗持续时间是24周。主要终点是均值变化在100年[percnt]对比视力在选定的“6月”基线眼睛(定义为眼睛视力最差的恶化,在过去3年)。其他端点包括视觉诱发电位、自动视野视野测量,光学相干断层扫描和病人报告结果的措施。结果:最后一个病人研究2015年8月完成。在2015年9月下旬数据库是锁着的。正在等待完整的统计分析。基线特征:93 MS患者(62复发与进步,31)从19个站点在法国和英国被随机分配。 Results of primary and secondary endpoints will be presented during the meeting. Conclusions: Results will be discussed in the context of development of high doses of pharmaceutical grade biotin as a novel treatment in MS. The study was supported by MedDay Pharmaceuticals

披露:Tourbah博士已经收到个人活动与补偿Idec, MedDay制药、Sanofi-Genzyme,诺华,默克公司Serono,和梯瓦制药公司作为顾问/讲师。阿恩特博士已经收到个人补偿活动与拜耳科学顾问委员会的成员。Vighetto博士没有披露。博士德Burghgraeve没有披露。博士Pelletier没有披露。Papeix博士没有披露。博士Lebrun Frenay没有披露。Labauge博士没有披露。Clanet博士没有披露。Toosy博士已经收到个人活动与生原体补偿Idec。 Dr. Laplaud has nothing to disclose. Dr. Vermersch has received personal compensation for activities with Biogen Idec, Sanofi, Bayer, Novartis, Merck Serono, GlaxoSmithKline, and Almirall. Dr. Vermersch has received research support from Biogen Idec, Sanofi, Bayer, and Merck Serono. Dr. Moreau has received personal compensation for activities with Biogen Idec, Sanofi-Aventis Pharmaceuticals, Genzyme corporation, Teva Neuroscience, Bayer Schering, Merck Serono, Novartis, and Almirall as a consultant. Dr. Debouverie has received research support from Biogen Idec, Genyzyme, Merk Serono, and Novartis. Dr. Clavelou has received personal compensation for activities with Genzyme, Teva, Novartis, Almirall, and Biogen Idec. Dr. Heinzlef has received personal compensation for activities with Genzyme as an advisory board member, from Almirail as a speaker, and Merck Serono as a consultant. Dr. De Seze has nothing to disclose. Dr. Defer has received research support from Novartis and Merck Serono Dr. Sedel holds stock and/or stock options in Medday Pharmaceuticals. Dr. Gout has nothing to disclose.