EUCTR2015-004783-11-ES进行中（未招募）1 期
A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Dose-Ranging Study to Evaluate the Safety and Efficacy of Intravenous Natalizumab (BG00002) in Acute Ischemic Stroke
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Clinical diagnosis of supratentorial acute ischemic stroke defined by LKN ?9 hours prior to study treatment initiation
- •- Score of 5 to 23 points, inclusive, on the NIHSS at Screening
- •- Prior to index stroke, patient was able to perform basic activities of daily living without assistance
- •- For those subjects who underwent a cranial MRI, there is at least 1 acute infarct with a diameter of ?2 cm on baseline brain diffusion-weighted imaging
- •NOTE: Other protocol-defined inclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 190
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •- Rapidly improving or minor stroke symptoms
- •- Lacunar or isolated brainstem stroke based on clinical assessment and available acute imaging studies
- •- Presence of acute intracranial hemorrhage on acute brain CT or MRI
- •- Severe stroke
- •NOTE: Other protocol-defined exclusion criteria may apply.
研究者
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