IV INFUSION OF ONO-2506 IN PATIENTS WITH ACUTE ISCHEMIC STROKE

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。本研究的主要目的是使用改进的Rankin量表（mRS）比较两种剂量水平的ONO-2506与安慰剂在急性缺血性卒中患者中的疗效。次要目的是评估ONO-2506在一项全球测试（包括mRS、NIH卒中量表、Barthel指数和格拉斯哥结果量表）中的疗效，并评估ONO-2506静脉输注在急性缺血性卒中患者中的安全性和耐受性。该研究的其他探索性目标是评估生活质量和测量血清s -1000- β蛋白水平。参加这项研究的患者将被随机分为三个剂量组，每天接受指定剂量的1小时输注，持续5天。三个治疗组分别为：ONO2506 4mg/kg/hr；ONO2506 10mg/kg/hr或安慰剂。第一剂盲法研究药物的施用必须在急性中风症状出现后不超过6小时开始。在给药阶段，每位患者将接受每日评估。在随访阶段，每位患者将在研究第13、30和90天接受评估。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The primary objective of this study is to compare the efficacy of two dose levels of ONO-2506 to placebo in patients with acute ischemic stroke using the modified Rankin Scale (mRS). The secondary objectives are to assess the efficacy of ONO-2506 in a Global Test (consisting of the mRS, NIH Stroke Scale, Barthel Index, and Glasgow Outcome Scale), and to evaluate the safety and tolerability of ONO-2506 intravenous infusion in patients with acute ischemic stroke. Other exploratory objectives of the study are to assess the quality of life and to measure serum S-1000-beta protein levels. Patients enrolled in this study will be randomized to one of three dose groups and will receive a one-hour infusion of an assigned dose daily for five days. The three treatment groups are: ONO2506 4mg/kg/hr; ONO2506 10mg/kg/hr or placebo. Administration of the first dose of blinded study medication must begin no more than six hours after onset of symptoms of acute stroke. During the dosing phase, each patient will undergo daily evaluations. During the follow-up phase, each patient will undergo evaluations on study day 13, 30 and 90.