[Translation] A multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy and safety of MT200605 in patients with acute ischemic stroke
主要目的:以治疗后第90天mRS评分达标的受试者比例,评估MT200605在急性缺血性卒中(AIS)患者中的疗效。
次要目的:
以治疗后14天内NIHSS评分较基线的变化,评估MT200605在AIS患者中的疗效;以治疗后90天内mRS评分达标情况,评估MT200605在AIS中的疗效;评估MT200605在急性缺血性卒中患者的安全性;以治疗后第30天、第90天Barthel指数(BI)评分≥95分的受试者比率来评估MT200605对日常生活能力的改善;以治疗后第30天、第90天EQ-5D的结果评估MT200605对生活质量的改善;评估MT200605在AIS中患者的药代动力学特征
[Translation] Primary Objective: To evaluate the efficacy of MT200605 in patients with acute ischemic stroke (AIS) by the proportion of subjects achieving target mRS scores on day 90 after treatment.
Secondary Objectives:
To evaluate the efficacy of MT200605 in patients with AIS by the change from baseline in NIHSS scores within 14 days after treatment; to evaluate the efficacy of MT200605 in patients with AIS by achieving target mRS scores within 90 days after treatment; to evaluate the safety of MT200605 in patients with acute ischemic stroke; to evaluate the improvement of MT200605 in activities of daily living by the proportion of subjects achieving Barthel Index (BI) scores ≥95 on days 30 and 90 after treatment; to evaluate the improvement of MT200605 in quality of life by EQ-5D results on days 30 and 90 after treatment; and to evaluate the pharmacokinetic characteristics of MT200605 in patients with AIS.