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Completed

NCT Number: NCT01996761

Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke

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.

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Key information

Conditions

Cerebrolysin

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

porcine brain peptide (Cerebrolysin)

Drug

Placebo

Drug

Primary outcomes

  1. the improvement ratio of Fugl-Meyer assessment

    Time frame: after 3 weeks

    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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Acronym: E-COMPASS

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 27, 2013
Registry last updated
May 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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