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Effects of Cerebrolysin Combined With Rehabilitation on Motor Recovery in Stroke

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02768571
Collaborator
Ever Neuro Pharma GmbH (Industry)
80
Enrollment
1
Location
2
Arms
35.1
Actual Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study, E-COMPASSII is a phase IV clinical trial designed as a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. This study will enroll 80 subacute stroke patients with severe motor involvement. 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. Secondary objectives are to evaluate the safety profile of cerebrolysin and to test the hypothesis that subacute stroke patients with severe motor involvement randomized to administration of Cerebrolysin combined with rehabilitation for 3 weeks show better outcome on global function (Korean version Modified Barthel Index, K-MBI), severity of stroke (National Institute of Health Stroke Scale, NIHSS), cognitive function (Korean Version of Mini-Mental State Exam, K-MMSE; Korean version Montreal Cognitive Assessment, K-MoCA), upper limb function (Action Research Arm Test, ARAT; Box and block test, B&B) and neuroplasticity measure (resting-state functional MRI(rsfMRI), diffusion tensor image(DTI), and motor evoked potential(MEP)) at 3 months after stroke.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Randomized double-blinded, placebo-controlled multicenter study with two treatment groups

Number of Patients: 80 patients (n = 40 per group) 5 study centers will participate in this study.

Group 1(Cerebrolysin): cerebrolysin 30 ml with 100 ml dilution/day * 21 days with rehabilitation

Group 2(Placebo): saline 100 ml/day * 21 days with rehabilitation

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Cerebrolysin Combined With Rehabilitation on Motor Recovery in Patients With Severe Motor Involvement at Subacute Phase of Stroke
Actual Study Start Date :
Mar 14, 2016
Actual Primary Completion Date :
Feb 14, 2019
Actual Study Completion Date :
Feb 14, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cerebrolysin

Cerebrolysin 30 ml with 100 ml dilution/day * 21 days with rehabilitation Study drug schedule - given from day 8 after stroke, but, if day 8 is weekend, the given day is the next Monday(day 9~10) Rehabilitation 3 hours (physiotherapy: 2 hours, occupational therapy: 1 hour) / day 5 times/week for 3 weeks Duration of Treatment: Study drug will be given once daily by intravenous infusion for 21 consecutive days on study day 8 ~ 28. The clinical observation period for each patient will be 90 days and will include four clinical evaluation visits at Screening(day ≤ 7), Baseline(day 8) and on study day 29, and 90.

Drug: Cerebrolysin
Cerebrolysin- cerebrolysin 30 ml with 100 ml dilution/day * 21 days with rehabilitation
Other Names:
  • Porcine brain peptide

    		•
    Placebo Comparator: Placebo

    Saline 100 ml/day * 21 days with rehabilitation Study drug schedule - given from day 8 after stroke, but, if day 8 is weekend, the given day is the next Monday(day 9~10) Rehabilitation 3 hours (physiotherapy: 2 hours, occupational therapy: 1 hour) / day 5 times/week for 3 weeks Duration of Treatment: Study drug will be given once daily by intravenous infusion for 21 consecutive days on study day 8 ~ 28. The clinical observation period for each patient will be 90 days and will include four clinical evaluation visits at Screening(day ≤ 7), Baseline(day 8) and on study day 29, and 90.

    Drug: Placebo
    Placebo- saline 100 ml/day * 21 days with rehabilitation
    Other Names:
  • Saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Score of Fugl-Meyer assessment (FMA) [3 months after stroke]

      Motor function

    Secondary Outcome Measures

    1. Score of Korean version Modified Barthel Index (K-MBI) [3 months after stroke]

      Global function

    2. Score of National Institute of Health Stroke Scale (NIHSS) [3 months after stroke]

      Severity of stroke

    3. Score of Korean Version of Mini-Mental State Exam(K-MMSE) and Korean version of Montreal Cognitive Assessment (K-MoCA) [3 months after stroke]

      Cognitive function

    4. Score of Action Research Arm Test (ARAT) and box and block test [3 months after stroke]

      Upper limb function

    5. Score of EuroQol (EQ-5D) [3 months after stroke]

      Quality of life

    6. Days of Length of hospital stay [3 months after stroke]

    7. Brain activation of resting-state functional MRI [3 months after stroke]

      Neuroplasticity measure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. The first-ever stroke (ischemic)

    2. Confirmed by CT or MRI

    3. Subacute stage: less than 1 week

    4. Severe motor function involvement (FMA < 50)

    5. Age: between 19 and 80 years

    6. Inpatients

    7. Written informed consent obtained from the patient or legally authorized representative

    Exclusion Criteria:

    1. Contraindication of MRI

    2. Progressive or unstable stroke

    3. Pre-existing and active major neurological disease

    4. Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia

    5. A history of significant alcohol or drug abuse in the prior 3 years

    6. Advanced liver, kidney, cardiac, or pulmonary disease

    7. A terminal medical diagnosis consistent with survival < 1 year

    8. Substantial decrease in alertness at the time of randomization, defined as score of 2 on NIH Stroke Scale

    9. Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years

    10. Any condition that would represent a contraindication to Cerebrolysin, including allergy to Cerebrolysin

    11. Current enrolment in another therapeutic study of stroke or stroke recovery

    12. 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.

    13. Previous porcine brain peptide administration history

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samsung Medical Center Seoul Korea, Republic of

    Sponsors and Collaborators

    • Samsung Medical Center
    • Ever Neuro Pharma GmbH

    Investigators

    • Study Chair: Yun-Hee Kim, MD, PhD, Samsung Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yun-Hee Kim, Professor, MD, PhD, Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT02768571
    Other Study ID Numbers:
    • 2015-10-034
    First Posted:
    May 11, 2016
    Last Update Posted:
    Sep 20, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Yun-Hee Kim, Professor, MD, PhD, Samsung Medical Center
    cerebrolysin, stroke, motor function
    Additional relevant MeSH terms:
    Stroke
    Cerebrolysin

    Study Results

    No Results Posted as of Sep 20, 2019