Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- the improvement ratio of Fugl-Meyer assessment
研究概览
简要总结
This study, E-COMPASS is a phase IV clinical trial designed as a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. This study will enroll 75 subacute stroke patients with unilateral motor dysfunction. Primary objective is to demonstrate the efficacy of porcine brain peptide to improve motor recovery measured by the improvement ratio of Fugl-Meyer assessment ((score of FMA after 3 weeks - score of FMA at baseline) / score of FMA at baseline) in patients with subacute 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1st cortical or subcortical unilateral infarction (supratentorial lesion)
- •Confirmed by CT or MRI
- •Subacute stage: less than 1 week
- •Moderate to severe motor function involvement-total of FMA: 0-84
- •Age: between 18 and 80 years
排除标准
- •Progressive or unstable stroke
- •Pre-existing and active major neurological disease
- •Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia
- •A history of significant alcohol or drug abuse in the prior 3 years
- •Advanced liver, kidney, cardiac, or pulmonary disease
- •A terminal medical diagnosis consistent with survival < 1 year
- •Substantial decrease in alertness at the time of randomization, defined as score of 2 on NIH Stroke Scale
- •Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years
- •Any condition that would represent a contraindication to Cerebrolysin, including allergy to Cerebrolysin
- •Current enrolment in another therapeutic study of stroke or stroke recovery
- •Total serum bilirubin > 4 mg/dL, alkaline phosphatase > 250 U/L, SGOT/AST > 150 U/L, SGPT/ALT > 150 U/L, or creatinine > 3.5 mg/dL; or cardiopulmonary deficits large enough to interfere with reasonable participation in physiotherapy during the trial.
- •Previous porcine brain peptide administration history
研究组 & 干预措施
Study Group 1
Study Group 1: 30ml Cerebrolysin
干预措施: porcine brain peptide (Cerebrolysin) (Drug)
Study Group 2
Study Group 2: Placebo (0.9% NaCl)
干预措施: Placebo (Drug)
结局指标
主要结局
the improvement ratio of Fugl-Meyer assessment
时间窗: after 3 weeks
Primary objective is to demonstrate the efficacy of porcine brain peptide to improve motor recovery measured by the improvement ratio of Fugl-Meyer assessment ((score of FMA after 3 weeks - score of FMA at baseline) / score of FMA at baseline) in patients with subacute stroke
次要结局
未报告次要终点
研究者
Yun-Hee Kim
Yun-Hee Kim
Samsung Medical Center