文摘
摘要目的:描述的基本原理和设计魅力,第三阶段研究评估是否静脉注射(IV)格列本脲(BIIB093)改善功能结果与大型参与者半球梗死(LHI)与安慰剂比较,90天。
背景:LHI是一种危及生命的缺血性中风发病率和死亡率高。严重的脑水肿是LHI常见的并发症。第四格列本脲抑制了SUR1 / TRPM4阳离子通道,可能由于LHI减少脑水肿。
设计/方法:魅力是一个全球性的、随机、多中心、双盲、安慰剂对照、III期试验(NCT02864953)。第1部分将评估功能结果在90天。第2部分将研究长期残疾在6 - 12个月。合格的参与者将18 - 85岁,急性缺血性中风的临床诊断与基线的大脑中动脉梗塞体积80厘米之间3和300厘米3评估diffusion-weighted磁共振成像(MRI)、计算机断层扫描(CT)灌注或阿尔伯塔中风项目早期CT评分(方面)1 - 5之间至少有2米地区,和用四格列本脲治疗输液10小时的最后的时间正常。参与者将被随机分配在1:1随机选择72小时连续注入四格列本脲或安慰剂和可接受标准护理治疗包括溶栓、血管内治疗。参与者将在基线资格进行成像和中线移位评估在72 - 96小时。主要终点是改良Rankin规模(夫人)≤70岁90天参与者分析转变分析使用5-category顺序量表(0/1和5/6崩溃)。
结果:2018年9月的魅力开始招生。
结论:魅力将包括~ ~ 22个国家的680名参与者。
披露:Sheth博士已经收到版税、许可费或合同权利支付从阿尔瓦的健康。Sheth博士已经收到了从生原体研究支持,诺华,吟游诗人,超精细。金伯利博士接到生原体研究支持。阿尔伯斯博士已经收到个人赔偿咨询、担任科学顾问委员会说,与iSchemaView或其他活动,美敦力公司,生原体。阿尔伯斯博士已经收到版税、许可费或合同权利支付从快速的软件。阿尔伯斯博士在iSchemaView持有股票或股票期权。Hinson博士接到生原体研究支持。Molyneaux博士没有披露。Nogueira博士已经收到个人赔偿咨询、担任科学顾问委员会说,与Stryker血管或其他活动,美敦力公司,Cerenovus / Neuravi Phenox,蟒蛇,基因泰克,生原体,延长药品,Viz.ai Coriundu。博士Nogueira Viz.ai持有股票或股票期权,Coriundus。 Dr. Saver has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, MedAvante, and BrainsGate. Dr. Steiner has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Bayer, Boehringer, BMS, Pfizer, and Daiichi Sankyo. Dr. Toyoda has nothing to disclose. Dr. Wintermark has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with MoreHealth, Magnetic Insight, Subtle Medical, Nines, icometrix, Biogen. Dr. Elkins has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. Dr. Elkins holds stock and/or stock options in Biogen which sponsored research in which Dr. Elkins was involved as an investigator. Dr. Deykin has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. Dr. Deykin holds stock and/or stock options in Biogen. Dr. Wald has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen. Dr. Wald holds stock and/or stock options in Biogen, which sponsored research in which Dr. Wald was involved as an investigator. Dr. Wald holds stock and/or stock options in Amgen, Medtronic, and AbbVie. Dr. Landen has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen.
