NCT04890353终止1 期
Impact of an Immune Modulator Dimethyl Fumarate on Acute Ischemic Stroke
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- National Institutes of Health Stroke Scale (NIHSS)
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 in alleviating neurologic deficits in patients with Acute Ischemic Stroke.
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
- Single (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
- •>18 y of age;
- •acute onset of focal neurological deficit consistent with acute ischemic stroke;
- •measurable neurological deficit (NIHSS ≥ 5);
- •anterior-circulation ischemic stroke defined by magnetic resonance angiography (MRA) and Diffusion-Weighted Imaging(DWI);
- •onset of symptom to admission more than 4.5 h and less than 72 h. Patients who arrived within 0-4.5 h poststroke were treated with other medications according to the best accepted medical treatment guidelines.
排除标准
- •Other diseases of the central nervous system
- •There has been neurological disability in the past (mRS score>2)
- •Difficulty swallowing
- •Arrhythmia, atrioventricular block
- •Use of anti-tumor drugs, other immunosuppressive and immunomodulatory drugs
- •Macular edema
- •MRA shows vertebral basilar artery obstruction
- •Hemorrhagic stroke
- •Patients who are known to have hypersensitivity to dimethyl fumarate or any excipients 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)
结局指标
主要结局
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.
Lesion Volume
时间窗: day 7
Measured by MRI.
次要结局
- Lesion Volume(day 90)
- The Modified Rankin Scale (mRS)(day90)
- National Institutes of Health Stroke Scale (NIHSS)(day 90)
研究者
研究点 (1)
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