Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke

Conditions
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Cerebrolysin

Intervention / Treatment
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* Drug: porcine brain peptide (Cerebrolysin)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1st cortical or subcortical unilateral infarction (supratentorial lesion) Confirmed by CT or MRI Subacute stage: less than 1 week Moderate to severe motor function involvement-total of FMA: 0-84 Age: between 18 and 80 years Inpatients Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group 1<br>Study Group 1: 30ml Cerebrolysin | Drug: porcine brain peptide (Cerebrolysin)<br> <br> |
| Placebo Comparator: Study Group 2<br>Study Group 2: Placebo (0.9% NaCl) | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the improvement ratio of Fugl-Meyer assessment | 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 | after 3 weeks |