Effects of Cerebrolysin Combined With Rehabilitation on Motor Recovery in Stroke

Stroke Clinical Trial

Official title:

Effects of Cerebrolysin Combined With Rehabilitation on Motor Recovery in Patients With Severe Motor Involvement at Subacute Phase of Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02768571
• Other study ID #: 2015-10-034
• Status: Completed
• Phase: Phase 4
• Start date: March 14, 2016
• Est. completion date: February 14, 2019

Study information

• Verified date: September 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 14, 2019
• Est. primary completion date: February 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Cerebrolysin
Cerebrolysin- cerebrolysin 30 ml with 100 ml dilution/day * 21 days with rehabilitation
• Placebo
Placebo- saline 100 ml/day * 21 days with rehabilitation

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Ever Neuro Pharma GmbH

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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