Effects of Cerebrolysin Combined With Rehabilitation on Motor Recovery in Stroke

NCT02768571 | Completed Phase 4 DMC

• 1 other identifier: 2015-10-034
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

cerebrolysin, stroke, motor function

Outcome Measures

Primary Outcomes (1)

• Score of Fugl-Meyer assessment (FMA)

  Motor function

  3 months after stroke

Secondary Outcomes (7)

• Score of Korean version Modified Barthel Index (K-MBI)

  3 months after stroke

• Score of National Institute of Health Stroke Scale (NIHSS)

  3 months after stroke

• Score of Korean Version of Mini-Mental State Exam(K-MMSE) and Korean version of Montreal Cognitive Assessment (K-MoCA)

  3 months after stroke

• Score of Action Research Arm Test (ARAT) and box and block test

  3 months after stroke

• Score of EuroQol (EQ-5D)

  3 months after stroke

Study Arms (2)

Cerebrolysin

EXPERIMENTAL

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.

Drug: Cerebrolysin

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Cerebrolysin DRUG

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

Also known as: Porcine brain peptide

Cerebrolysin

Placebo DRUG

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

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The first-ever stroke (ischemic)
• Confirmed by CT or MRI
• Subacute stage: less than 1 week
• Severe motor function involvement (FMA \< 50)
• Age: between 19 and 80 years
• Inpatients
• Written informed consent obtained from the patient or legally authorized representative

You may not qualify if:

• Contraindication of MRI
• Progressive or unstable stroke
• Pre-existing and active major neurological disease
• Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia
• A history of significant alcohol or drug abuse in the prior 3 years
• Advanced liver, kidney, cardiac, or pulmonary disease
• A terminal medical diagnosis consistent with survival \< 1 year
• Substantial decrease in alertness at the time of randomization, defined as score of 2 on NIH Stroke Scale
• Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years
• Any condition that would represent a contraindication to Cerebrolysin, including allergy to Cerebrolysin
• Current enrolment in another therapeutic study of stroke or stroke recovery
• 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.
• Previous porcine brain peptide administration history

Sponsors & Collaborators

• Samsung Medical Center: lead
• Ever Neuro Pharma GmbH: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Stroke

Interventions

cerebrolysin; brain natriuretic peptide, porcine; Sodium Chloride

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Yun-Hee Kim, MD, PhD

  Samsung Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: May 11, 2016
• Study Start: March 14, 2016
• Primary Completion: February 14, 2019
• Study Completion: February 14, 2019
• Last Updated: September 20, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)