Cerebrolysin
Conditions
Brief summary
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.
Interventions
DRUGporcine brain peptide (Cerebrolysin)
DRUGPlacebo
Sponsors
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
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 1st cortical or subcortical unilateral infarction (supratentorial lesion) 2. Confirmed by CT or MRI 3. Subacute stage: less than 1 week 4. Moderate to severe motor function involvement-total of FMA: 0-84 5. Age: between 18 and 80 years 6. Inpatients
Exclusion criteria
1. Progressive or unstable stroke 2. Pre-existing and active major neurological disease 3. Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia 4. A history of significant alcohol or drug abuse in the prior 3 years 5. Advanced liver, kidney, cardiac, or pulmonary disease 6. A terminal medical diagnosis consistent with survival \< 1 year 7. Substantial decrease in alertness at the time of randomization, defined as score of 2 on NIH Stroke Scale 8. Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years 9. Any condition that would represent a contraindication to Cerebrolysin, including allergy to Cerebrolysin 10. Current enrolment in another therapeutic study of stroke or stroke recovery 11. 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. 12. Previous porcine brain peptide administration history
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the improvement ratio of Fugl-Meyer assessment | 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 |
Countries
South Korea
Outcome results
None listed