Effects of Cerebrolysin Combined With Rehabilitation on Motor Recovery in Stroke

NCTNCT02768571Other id2015-10-034

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Overview

Status: Completed
Phase: Phase 4
Enrollment: 80 participants (actual)
Sponsor: Samsung Medical Center · Other
Design: Randomized · Quadruple masking
Countries: 1 country
South Korea
Start: 14 Mar 2016
Primary completion: 14 Feb 2019
Completion: 14 Feb 2019
First posted: 11 May 2016 (estimated)
Last update posted: 20 Sept 2019
Conditions: Stroke

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20162017201820192020

Ph 4
Effects of Cerebrolysin Combined With Rehabilitation on Motor Recovery in Stroke
NCT02768571
14 Mar 2016 to 14 Feb 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

CerebrolysinDrug
PlaceboDrug

Arms2

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.
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Score of Fugl-Meyer assessment (FMA)
Time frame · 3 months after stroke
Registry description
Motor function

Secondary outcomes(7)

Score of Korean version Modified Barthel Index (K-MBI)
Time frame · 3 months after stroke
Registry description
Global function
Score of National Institute of Health Stroke Scale (NIHSS)
Time frame · 3 months after stroke
Registry description
Severity of stroke
Score of Korean Version of Mini-Mental State Exam(K-MMSE) and Korean version of Montreal Cognitive Assessment (K-MoCA)
Time frame · 3 months after stroke
Registry description
Cognitive function
Score of Action Research Arm Test (ARAT) and box and block test
Time frame · 3 months after stroke
Registry description
Upper limb function
Score of EuroQol (EQ-5D)
Time frame · 3 months after stroke
Registry description
Quality of life
Days of Length of hospital stay
Time frame · 3 months after stroke
Brain activation of resting-state functional MRI
Time frame · 3 months after stroke
Registry description
Neuroplasticity measure

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 19 Years up to 80 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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