A Phase IIa Randomized, Double-Blind, Parallel-Groups, Placebo Controlled Clinical Trial to Study the Efficacy and Safety of MK0724 Intravenous Infusion on the Amelioration of Neurological Damage and Recovery From Middle Cerebral Artery Ischemic Stroke

Merck Sharp & Dohme LLC0 个研究点目标入组 150 人开始时间: 2007年7月最近更新: 2015年7月22日

适应症

试验速览

阶段: 2 期
状态: 终止
发起方: Merck Sharp & Dohme LLC
入组人数: 150
主要终点: Action Research Arm Test score

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The safety and efficacy of MK0724 will be assessed in patients with acute middle cerebral artery stroke using the Action Reach Arm Test (ARAT). This test allows measurement of a specific functional deficit and subsequent recovery correlating with the specific area of stroke in the brain.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•18-80 yrs of age inclusive
•Patient is able to receive IV infusion 8-36 hours after stroke onset
•Baseline NIHSS of 6-18 inclusive

排除标准

•Patient had another stroke within 3 months preceding current stroke, patient's stroke is of origin other than MCA (e.g., non-ischemic, hemorrhage), significant cerebral edema, abnormal liver enzymes and abnormal renal and hepatic functions

结局指标

主要结局

Action Research Arm Test score

时间窗: At 90 days

次要结局

Scores on the Stroke Arm Strength question, modified Rankin, and Barthel Index.(At 90 days)

研究者

发起方

Merck Sharp & Dohme LLC

申办方类型

Industry

责任方

Sponsor

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