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

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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.