NCT00868283

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

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,071 (actual)
• Sponsor: Ever Neuro Pharma GmbH · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Cerebrolysin	30 ml study drug will be given once daily by intravenous infusion for 10 consecutive days.
DRUG	0.9% Saline Solution	30 ml will be given once daily by intravenous infusion for 10 consecutive days.

Timeline

• Start date: 2006-09-01
• Primary completion: 2010-10-01
• Completion: 2011-02-01
• First posted: 2009-03-24
• Last updated: 2023-12-15

Locations

49 sites across 3 countries: China, Hong Kong, South Korea