NCT02768571

Effects of Cerebrolysin Combined With Rehabilitation on Motor Recovery in Stroke

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Cerebrolysin	Cerebrolysin- cerebrolysin 30 ml with 100 ml dilution/day \* 21 days with rehabilitation
DRUG	Placebo	Placebo- saline 100 ml/day \* 21 days with rehabilitation

Timeline

• Start date: 2016-03-14
• Primary completion: 2019-02-14
• Completion: 2019-02-14
• First posted: 2016-05-11
• Last updated: 2019-09-20

Locations

1 site across 1 country: South Korea