Effects of Cerebrolysin Combined With Rehabilitation on Motor Recovery in Patients With Severe Motor Involvement at Subacute Phase of Stroke
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Score of Fugl-Meyer assessment (FMA)
研究概览
简要总结
This study, E-COMPASSII is a phase IV clinical trial designed as a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. This study will enroll 80 subacute stroke patients with severe motor involvement. 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. Secondary objectives are to evaluate the safety profile of cerebrolysin and to test the hypothesis that subacute stroke patients with severe motor involvement randomized to administration of Cerebrolysin combined with rehabilitation for 3 weeks show better outcome on global function (Korean version Modified Barthel Index, K-MBI), severity of stroke (National Institute of Health Stroke Scale, NIHSS), cognitive function (Korean Version of Mini-Mental State Exam, K-MMSE; Korean version Montreal Cognitive Assessment, K-MoCA), upper limb function (Action Research Arm Test, ARAT; Box and block test, B&B) and neuroplasticity measure (resting-state functional MRI(rsfMRI), diffusion tensor image(DTI), and motor evoked potential(MEP)) at 3 months after stroke.
详细描述
Randomized double-blinded, placebo-controlled multicenter study with two treatment groups
Number of Patients: 80 patients (n = 40 per group) 5 study centers will participate in this study.
Group 1(Cerebrolysin): cerebrolysin 30 ml with 100 ml dilution/day * 21 days with rehabilitation
Group 2(Placebo): saline 100 ml/day * 21 days with rehabilitation
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
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The first-ever stroke (ischemic)
- •Confirmed by CT or MRI
- •Subacute stage: less than 1 week
- •Severe motor function involvement (FMA < 50)
- •Age: between 19 and 80 years
- •Written informed consent obtained from the patient or legally authorized representative
排除标准
- •Contraindication of MRI
- •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
Cerebrolysin
Cerebrolysin 30 ml with 100 ml dilution/day * 21 days with rehabilitation
-
Study drug schedule - given from day 8 after stroke, but, if day 8 is weekend, the given day is the next Monday(day 9~10)
-
Rehabilitation
-
3 hours (physiotherapy: 2 hours, occupational therapy: 1 hour) / day
-
5 times/week for 3 weeks
Duration of Treatment:
Study drug will be given once daily by intravenous infusion for 21 consecutive days on study day 8 ~ 28.
The clinical observation period for each patient will be 90 days and will include four clinical evaluation visits at Screening(day ≤ 7), Baseline(day 8) and on study day 29, and 90.
干预措施: Cerebrolysin (Drug)
Placebo
Saline 100 ml/day * 21 days with rehabilitation
-
Study drug schedule - given from day 8 after stroke, but, if day 8 is weekend, the given day is the next Monday(day 9~10)
-
Rehabilitation
-
3 hours (physiotherapy: 2 hours, occupational therapy: 1 hour) / day
-
5 times/week for 3 weeks
Duration of Treatment:
Study drug will be given once daily by intravenous infusion for 21 consecutive days on study day 8 ~ 28.
The clinical observation period for each patient will be 90 days and will include four clinical evaluation visits at Screening(day ≤ 7), Baseline(day 8) and on study day 29, and 90.
干预措施: Placebo (Drug)
结局指标
主要结局
Score of Fugl-Meyer assessment (FMA)
时间窗: 3 months after stroke
Motor function
次要结局
- Score of Korean Version of Mini-Mental State Exam(K-MMSE) and Korean version of Montreal Cognitive Assessment (K-MoCA)(3 months after stroke)
- Score of EuroQol (EQ-5D)(3 months after stroke)
- Score of National Institute of Health Stroke Scale (NIHSS)(3 months after stroke)
- Score of Korean version Modified Barthel Index (K-MBI)(3 months after stroke)
- Days of Length of hospital stay(3 months after stroke)
- Score of Action Research Arm Test (ARAT) and box and block test(3 months after stroke)
- Brain activation of resting-state functional MRI(3 months after stroke)
研究者
Yun-Hee Kim
Professor, MD, PhD
Samsung Medical Center