EUCTR2015-004783-11-DE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
适应症
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 =24 hours prior to study treatment initiation.
- •- Score of 5 to 23 points, inclusive, on the NIHSS at Screening for
- •subjects initiating treatment =9 hours from LKN. Note: NIHSS eligibility
- •must be confirmed within 60 minutes prior to randomization.
- •- Score of 5 to 15 points, inclusive, on the NIHSS at Screening for
- •subjects initiating treatment >9 to =24 hours from LKN. Note: NIHSS
- •eligibility must be confirmed within 60 minutes prior to randomization.
- •- Prior to index stroke, patient was able to perform basic activities of
- •daily living without assistance: dressing, eating, walking, bathing, and
- •using the toilet.
- •- For those subjects who underwent a cranial MRI, there is at least 1
- •acute infarct with a diameter of =2 cm on baseline brain diffusionweighted
- •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
- •- Lacunar or isolated brainstem or cerebellar stroke based on clinical assessment and available acute imaging studies performed under the
- •standard of care.
- •- Presence of acute intracranial hemorrhage on acute brain CT or MRI.
- •However, petechial hemorrhages of =1 cm are not exclusionary.
- •- Severe stroke.
- •- Seizure at the onset of stroke.
- •- Known history of prior treatment with natalizumab.
- •- Known history of active viral hepatitis B or C.
- •- Signs and symptoms of active or acute infection.
- •NOTE: Other protocol-defined exclusion criteria may apply.
研究者
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