洛贝拉米萨尔治疗急性缺血性中风 (LAIS):一个多中心,随机,双盲,并行,安慰剂控制的III期临床试验
Shuya Li1,2,3, Xuechun Wang2, Baoyu Feng2
1Department of Neurology, Beijing Tiantan Hospital Affiliated to Capital Medical University, Beijing, China.
Stroke and vascular neurology
|December 4, 2025
概括
洛贝拉米萨尔作为急性缺血性中风 (AIS) 的神经保护剂具有前景. 这一第三阶段试验评估了在中风发作后48小时内接受治疗的患者的疗效和安全性.
科学领域:
- 神经科学是一个神经科学.
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 洛贝拉米萨尔是一种新型神经保护剂,可以解离后突触密度蛋白95/神经氧化合成酶复合体.
- 它增强了含有α2的γ-氨基黄油酸A型受体,在急性缺血性中风的临床前模型中显示出有效性.
研究的目的:
- 评估静脉输入洛贝拉米萨尔在急性缺血性中风 (AIS) 患者的疗效和安全性.
- 评估洛贝拉米萨尔作为AIS治疗新型神经保护剂的潜力,在发病后48小时内.
主要方法:
- 一个多中心,前性,随机,双盲,安慰剂控制的第三期试验 (LAIS试验).
- 998名符合条件的患者将随机分配,以1:1的比例接受洛贝拉米萨尔或安慰剂.
- 主要结局:在90天内达到修改兰金度表 (mRS) 0-1的患者比例.
主要成果:
- 主要疗效结局是获得优异功能结局的个体比例 (90天的mRS 0-1).
- 二次结果包括不同时间点的各种功能结果措施 (mRS,NIHSS减少,Barthel指数).
- 安全结果包括对不良事件的监测;探索性结果评估抑郁和焦虑症状.
结论:
- 该LAIS试验旨在严格评估洛贝拉米萨尔的治疗潜力.
- 这项研究将确定洛贝拉米萨尔是否可以为患有急性缺血性中风的患者提供新的神经保护策略.
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