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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01996761
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : May 11, 2016
Sponsor:
Information provided by (Responsible Party):
Yun-Hee Kim, Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE November 5, 2013
First Posted Date  ICMJE November 27, 2013
Last Update Posted Date May 11, 2016
Study Start Date  ICMJE January 2011
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01996761 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke
Official Title  ICMJE Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cerebrolysin
Intervention  ICMJE
  • Drug: porcine brain peptide (Cerebrolysin)
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Study Group 1
    Study Group 1: 30ml Cerebrolysin
    Intervention: Drug: porcine brain peptide (Cerebrolysin)
  • Placebo Comparator: Study Group 2
    Study Group 2: Placebo (0.9% NaCl)
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2016)
71
Original Estimated Enrollment  ICMJE
 (submitted: November 26, 2013)
75
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01996761
Other Study ID Numbers  ICMJE 2010-09-084-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yun-Hee Kim, Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Samsung Medical Center
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP