Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke "E-COMPASS"

Completed

Phase 4 Results N/A

Trial Description

This study, E-COMPASS is a phase IV clinical trial designed as a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. This study will enroll 75 subacute stroke patients with unilateral motor dysfunction. 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.

Conditions

Interventions

  • Placebo Drug
    ARM 1: Kind: Experimental
    Label: Study Group 2
    Description: Study Group 2: Placebo (0.9% NaCl)
  • Porcine brain peptide (Cerebrolysin) Drug
    ARM 1: Kind: Experimental
    Label: Study Group 1
    Description: Study Group 1: 30ml Cerebrolysin

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary the improvement ratio of Fugl-Meyer assessment after 3 weeks Yes

Sponsors