Stroke
Conditions
Keywords
cerebrolysin, stroke, motor function
Brief summary
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.
Detailed description
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
Interventions
DRUGCerebrolysin
Cerebrolysin- cerebrolysin 30 ml with 100 ml dilution/day \* 21 days with rehabilitation
DRUGPlacebo
Placebo- saline 100 ml/day \* 21 days with rehabilitation
Sponsors
Ever Neuro Pharma GmbH
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. The first-ever stroke (ischemic) 2. Confirmed by CT or MRI 3. Subacute stage: less than 1 week 4. Severe motor function involvement (FMA \< 50) 5. Age: between 19 and 80 years 6. Inpatients 7. Written informed consent obtained from the patient or legally authorized representative
Exclusion criteria
1. Contraindication of MRI 2. Progressive or unstable stroke 3. Pre-existing and active major neurological disease 4. Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia 5. A history of significant alcohol or drug abuse in the prior 3 years 6. Advanced liver, kidney, cardiac, or pulmonary disease 7. A terminal medical diagnosis consistent with survival \< 1 year 8. Substantial decrease in alertness at the time of randomization, defined as score of 2 on NIH Stroke Scale 9. Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years 10. Any condition that would represent a contraindication to Cerebrolysin, including allergy to Cerebrolysin 11. Current enrolment in another therapeutic study of stroke or stroke recovery 12. 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. 13. Previous porcine brain peptide administration history
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score of Fugl-Meyer assessment (FMA) | 3 months after stroke | Motor function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Score of National Institute of Health Stroke Scale (NIHSS) | 3 months after stroke | Severity of stroke |
| Score of Korean Version of Mini-Mental State Exam(K-MMSE) and Korean version of Montreal Cognitive Assessment (K-MoCA) | 3 months after stroke | Cognitive function |
| Score of Action Research Arm Test (ARAT) and box and block test | 3 months after stroke | Upper limb function |
| Score of Korean version Modified Barthel Index (K-MBI) | 3 months after stroke | Global function |
| Days of Length of hospital stay | 3 months after stroke | — |
| Brain activation of resting-state functional MRI | 3 months after stroke | Neuroplasticity measure |
| Score of EuroQol (EQ-5D) | 3 months after stroke | Quality of life |
Countries
South Korea
Outcome results
None listed