Effects of Cerebrolysin Combined With Rehabilitation on Motor Recovery in Stroke
Stroke

About this trial
This is an interventional treatment trial for Stroke focused on measuring cerebrolysin, stroke, motor function
Eligibility Criteria
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
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Cerebrolysin
Placebo
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.
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.