Effects of Cerebrolysin Combined With Rehabilitation on Motor Recovery in Stroke

Phase 4

Completed

• Conditions: Stroke
• Interventions: Drug: Placebo; Drug: Cerebrolysin

• Registration Number: NCT02768571
• Lead Sponsor: Samsung Medical Center

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

Study Timeline

• Study First Submitted: 2016-03-04
• Study Start: 2016-03-14
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-11
• Primary Completion: 2019-02-14
• Study Completion: 2019-02-14
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-18
• Last Update Posted: 2019-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Cerebrolysin	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.

Primary Outcome Measures

Name	Time	Method
Score of Fugl-Meyer assessment (FMA)	3 months after stroke	Motor function

Secondary Outcome Measures

Name	Time	Method
Score of EuroQol (EQ-5D)	3 months after stroke	Quality of life
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
Score of National Institute of Health Stroke Scale (NIHSS)	3 months after stroke	Severity of stroke
Score of Korean version Modified Barthel Index (K-MBI)	3 months after stroke	Global function
Days of Length of hospital stay	3 months after stroke
Score of Action Research Arm Test (ARAT) and box and block test	3 months after stroke	Upper limb function
Brain activation of resting-state functional MRI	3 months after stroke	Neuroplasticity measure

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of