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

NCT00868283 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1071

Last updated 2023-12-15

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Excel PharmaStudies, Inc.

    collaborator INDUSTRY

  • idv Datenanalyse und Versuchsplanung

    collaborator UNKNOWN

  • Ever Neuro Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Philipp Novak, PhD · EVER Neuro Pharma

  • Zhen Hong, MD · Huashan Hospital, affiliated Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2010-10-31
Completion
2011-02-28

Countries

  • China
  • Hong Kong
  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00868283 on ClinicalTrials.gov