Effects of Cerebrolysin Combined With Rehabilitation on Motor Recovery in Stroke

NCT ID: NCT02768571

Last Updated: 2019-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-14
• Study Completion Date: 2019-02-14

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

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cerebrolysin

Intervention Type: DRUG

Cerebrolysin- cerebrolysin 30 ml with 100 ml dilution/day \* 21 days with rehabilitation

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo- saline 100 ml/day \* 21 days with rehabilitation

Interventions

Cerebrolysin

Cerebrolysin- cerebrolysin 30 ml with 100 ml dilution/day \* 21 days with rehabilitation

Intervention Type: DRUG

Placebo

Placebo- saline 100 ml/day \* 21 days with rehabilitation

Intervention Type: DRUG

Other Intervention Names

Porcine brain peptide; Saline

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ever Neuro Pharma GmbH

INDUSTRY

Sponsor Role: collaborator

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Yun-Hee Kim

Professor, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yun-Hee Kim, MD, PhD

Role: STUDY_CHAIR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2015-10-034

Identifier Type: -

Identifier Source: org_study_id