Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke

NCT01996761 | Completed Phase 4

• 1 other identifier: 2010-09-084-001
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebrolysin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Study Group 1

EXPERIMENTAL

Study Group 1: 30ml Cerebrolysin

Drug: porcine brain peptide (Cerebrolysin)

Study Group 2

PLACEBO COMPARATOR

Study Group 2: Placebo (0.9% NaCl)

Drug: Placebo

Interventions

porcine brain peptide (Cerebrolysin) DRUG

Study Group 1

Placebo DRUG

Study Group 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• st 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

• 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.

  PMID: 26934986 DERIVED

MeSH Terms

Interventions

cerebrolysin

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Yun-Hee Kim

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 27, 2013
• Study Start: January 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: May 11, 2016

Record last verified: 2016-05

Locations

KR (1)