Clinical trial NCT02768571: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stroke
Keywords: cerebrolysin, stroke, motor function
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Ever Neuro Pharma GmbH
First posted: 2016-05-11
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Score of Fugl-Meyer assessment (FMA)
timeFrame: 3 months after stroke
Secondary outcomes:
measure: Score of Korean version Modified Barthel Index (K-MBI)
timeFrame: 3 months after stroke
measure: Score of National Institute of Health Stroke Scale (NIHSS)
timeFrame: 3 months after stroke
measure: Score of Korean Version of Mini-Mental State Exam(K-MMSE) and Korean version of Montreal Cognitive Assessment (K-MoCA)
timeFrame: 3 months after stroke
measure: Score of Action Research Arm Test (ARAT) and box and block test
timeFrame: 3 months after stroke
measure: Score of EuroQol (EQ-5D)
timeFrame: 3 months after stroke
measure: Days of Length of hospital stay
timeFrame: 3 months after stroke
measure: Brain activation of resting-state functional MRI
timeFrame: 3 months after stroke
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Yun-Hee Kim, MD, PhD
role: STUDY_CHAIR
References: