EUCTR2017-004854-41-IT进行中（未招募）1 期
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema following Large Hemispheric Infarction - CHARM
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 535
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
- •1.A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory
- •2.A large hemispheric infarction defined as; lesion volume of 80 to 300 centimeters cubed (cm^3) on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI), or computed tomography perfusion (CTP), or an Alberta Stroke Program Early CT Score (ASPECTS) of 1 to 5 with involvement of at least 2 defined cortical regions
- •3. Screening National Institutes of Health Stroke Scale (NIHSS) >=10
- •4. Study treatment infusion within 10 hours after time of symptom onset, if known, or the time last known normal
- •5. For participants who receive thrombectomy, inclusion into the study must be based on post-thrombectomy MRI-DWI
- •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 102
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 578
排除标准
- •1.Participant is likely to have supportive care withdrawn on the first day
- •2.Commitment to decompressive craniectomy (DC) prior to enrollment
- •3.Evidence of concurrent infarction in the contralateral hemisphere sufficiently serious so as to affect functional outcome
- •NOTE: Other protocol defined Exclusion criteria may apply
研究者
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