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Trial · Interventional

CompletedPhase 4Registry data

Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke

Short name E-COMPASS

Overview

Status
Completed
Phase
Phase 4
Enrollment
71 participants (actual)
Sponsor
Samsung Medical Center · Other
Design
Randomized · Quadruple masking
Countries
1 country

South Korea

Start
Jan 2011
Primary completion
Jan 2014
Completion
Feb 2014
First posted
27 Nov 2013 (estimated)
Last update posted
11 May 2016 (estimated)
Conditions
Cerebrolysin

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20112012201320142015
  1. Ph 4

    E-COMPASS

    NCT01996761

    Jan 2011 to Feb 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • porcine brain peptide (Cerebrolysin)Drug
  • PlaceboDrug

Arms2

  • Experimental

    Study Group 1

    Study Group 1: 30ml Cerebrolysin

  • Placebo comparator

    Study Group 2

    Study Group 2: Placebo (0.9% NaCl)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. the improvement ratio of Fugl-Meyer assessment

    Time frame · after 3 weeks

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2016

4 results

Cerebrolysin combined with rehabilitation promotes motor recovery in patients with severe motor impairment after stroke.

Chang et al. 2016BMC neurologycited by 53

PMID 26934986PMC4776414DOI 10.1186/s12883-016-0553-zPUB-26934986

CC BY4 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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