Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke (E-COMPASS)

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.

Study Overview

• Status: Completed
• Conditions: Cerebrolysin
• Intervention / Treatment: Drug: Placebo; Drug: porcine brain peptide (Cerebrolysin)

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Publications and helpful links

General Publications

• Chang WH, Park CH, Kim DY, Shin YI, Ko MH, Lee A, Jang SY, Kim YH. Cerebrolysin combined with rehabilitation promotes motor recovery in patients with severe motor impairment after stroke. BMC Neurol. 2016 Mar 2;16:31. doi: 10.1186/s12883-016-0553-z.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: November 5, 2013
• First Submitted That Met QC Criteria: November 26, 2013
• First Posted (Estimate): November 27, 2013

Study Record Updates

• Last Update Posted (Estimate): May 11, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neuroprotective Agents; Protective Agents; Nootropic Agents; Cerebrolysin
• Other Study ID Numbers: 2010-09-084-001