The Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke "CASTA"

Completed

Phase 4 Results N/A

Trial Description

The study investigated the clinical efficacy and safety of a 10-day course of therapy with daily intravenous administration of 30mL Cerebrolysin based on a comparison with Placebo in patients with acute ischemic stroke. 1070 patients were randomized in this trial in 2 parallel groups, one receiving Cerebrolysin, the control group receiving Placebo. Study drug will be given once daily by intravenous infusion for 10 consecutive days. Acetylsalicylic acid will be given orally, once daily throughout the study duration of 90 days as basic treatment. The clinical observation period for each patient will be 3 months and will include six clinical evaluation visits at Baseline (day 1) and on study days 2, 5, 10, 30 and 90.

Conditions

Interventions

  • Cerebrolysin Drug
    Other Names: Ever Pharma, Unterach am Attersee, Austria
    Intervention Desc: 30 ml study drug will be given once daily by intravenous infusion for 10 consecutive days.
    ARM 1: Kind: Experimental
    Label: Cerebrolysin
  • 0.9% Saline Solution Drug
    Other Names: NaCl
    Intervention Desc: 30 ml will be given once daily by intravenous infusion for 10 consecutive days.
    ARM 1: Kind: Experimental
    Label: 0.9% Saline Solution

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 Modified Rankin Scale 90 days after start of treatment No
Primary Barthel Index 90 days after start of treatment No
Primary NIH Stroke Scale 90 days after start of treatment No
Secondary SF-12 90 days after start of treatment No
Secondary Overall mortality Throughout the study Yes

Sponsors