NCT04890379撤回2 期
Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Volume of Perihematomal edema(PHE)
研究概览
简要总结
The investigators conduct this study to investigate whether oral administration of Dimethyl Fumarate, a Food and Drug Administration-approved drug for multiple sclerosis, is safe and effective in alleviating PHE and neurologic deficits in patients with ICH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and nonpregnant women aged 18 years and older
- •a primary supratentorial ICH of 5 to 30 mL
- •symptom onset less than 72 hours prior to admission
- •a Glasgow Coma Scale (GCS) score of 6 or greater
- •basal ganglia hemorrhage only
排除标准
- •patients with a GCS score of 3 to 5
- •planned surgical evacuation of a large hematoma (>30 mL)
- •various degrees of dysphagia,and nausea/vomiting, any of which renders oral administration of fingolimod difficult
- •patients with hematoma expansion
- •secondary ICH
- •preexisting disability (modified Rankin Scale [mRS] score >1)
- •any history of bradycardia or atrioventricular block
- •concomitant use of antineoplastic, immunosuppressive, or immune-modulating therapies
- •macular edema
- •Patients with known hypersensitivity to dimethyl fumarate or to any excipient of this product
- •Pregnant and lactating women
研究组 & 干预措施
standard management plus Dimethyl Fumarate
Experimental
干预措施: Dimethyl fumarate (Drug)
standard management plus placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Volume of Perihematomal edema(PHE)
时间窗: day7
measured by MRI
Glasgow Coma Scale (GCS)
时间窗: day7
The GCS score ranges from 3 to 15 points. The lower the score, the more severe the patient's coma is.
National Institutes of Health Stroke Scale (NIHSS)
时间窗: day 7
The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.
次要结局
- Volume of Perihematomal edema(PHE)(day90)
- The Modified Barthel Index (mBI)(day 90)
- National Institutes of Health Stroke Scale (NIHSS)(day90)
- The Modified Rankin Scale (mRS)(day90)
- Glasgow Coma Scale (GCS)(day 14)
研究者
研究点 (1)
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