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Effects of Cerebrolysin Combined With Rehabilitation on Motor Recovery in Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cerebrolysin
Placebo
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring cerebrolysin, stroke, motor function

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cerebrolysin

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Score of Fugl-Meyer assessment (FMA)
Motor function

Secondary Outcome Measures

Score of Korean version Modified Barthel Index (K-MBI)
Global function
Score of National Institute of Health Stroke Scale (NIHSS)
Severity of stroke
Score of Korean Version of Mini-Mental State Exam(K-MMSE) and Korean version of Montreal Cognitive Assessment (K-MoCA)
Cognitive function
Score of Action Research Arm Test (ARAT) and box and block test
Upper limb function
Score of EuroQol (EQ-5D)
Quality of life
Days of Length of hospital stay
Brain activation of resting-state functional MRI
Neuroplasticity measure

Full Information

First Posted
March 4, 2016
Last Updated
September 18, 2019
Sponsor
Samsung Medical Center
Collaborators
Ever Neuro Pharma GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02768571
Brief Title
Effects of Cerebrolysin Combined With Rehabilitation on Motor Recovery in Stroke
Official Title
Effects of Cerebrolysin Combined With Rehabilitation on Motor Recovery in Patients With Severe Motor Involvement at Subacute Phase of Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 14, 2016 (Actual)
Primary Completion Date
February 14, 2019 (Actual)
Study Completion Date
February 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
Ever Neuro Pharma GmbH

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
cerebrolysin, stroke, motor function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cerebrolysin
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cerebrolysin
Other Intervention Name(s)
Porcine brain peptide
Intervention Description
Cerebrolysin- cerebrolysin 30 ml with 100 ml dilution/day * 21 days with rehabilitation
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
Placebo- saline 100 ml/day * 21 days with rehabilitation
Primary Outcome Measure Information:
Title
Score of Fugl-Meyer assessment (FMA)
Description
Motor function
Time Frame
3 months after stroke
Secondary Outcome Measure Information:
Title
Score of Korean version Modified Barthel Index (K-MBI)
Description
Global function
Time Frame
3 months after stroke
Title
Score of National Institute of Health Stroke Scale (NIHSS)
Description
Severity of stroke
Time Frame
3 months after stroke
Title
Score of Korean Version of Mini-Mental State Exam(K-MMSE) and Korean version of Montreal Cognitive Assessment (K-MoCA)
Description
Cognitive function
Time Frame
3 months after stroke
Title
Score of Action Research Arm Test (ARAT) and box and block test
Description
Upper limb function
Time Frame
3 months after stroke
Title
Score of EuroQol (EQ-5D)
Description
Quality of life
Time Frame
3 months after stroke
Title
Days of Length of hospital stay
Time Frame
3 months after stroke
Title
Brain activation of resting-state functional MRI
Description
Neuroplasticity measure
Time Frame
3 months after stroke

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The first-ever stroke (ischemic) Confirmed by CT or MRI Subacute stage: less than 1 week Severe motor function involvement (FMA < 50) Age: between 19 and 80 years Inpatients Written informed consent obtained from the patient or legally authorized representative Exclusion Criteria: Contraindication of MRI 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun-Hee Kim, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Cerebrolysin Combined With Rehabilitation on Motor Recovery in Stroke

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