Effects of Cerebrolysin Combined With Rehabilitation on Motor Recovery in Stroke

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

Inclusion criteria

• 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
• Inpatients
• Written informed consent obtained from the patient or legally authorized representative

Exclusion criteria

• 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