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Efficacy and Safety Study of DP-b99 in Treating Acute Ischemic Stroke

NCT00893867 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 446

Last updated 2012-10-24

No results posted yet for this study

Summary

The purpose of this trial is to determine if intravenous administration of the metal ion trapping agent DP-b99 up to 9 hours following acute ischemic stroke onset, and then for 3 additional days (4 consecutive days in total) is effective in improving long term outcome. Patients will be followed up for 3 months after the stroke.

Conditions

  • Acute Ischemic Stroke

Interventions

DRUG

DP-b99

1mg/kg/day over 4 consecutive days given intravenously and initiated up to 9 hours following acute stroke onset.

DRUG

Placebo

1mg/kg/day over 4 consecutive days given intravenously and initiated up to 9 hours following acute stroke onset.

Sponsors & Collaborators

  • D-Pharm Ltd.

    lead INDUSTRY

Principal Investigators

  • Ashfaq Shuaib, MD · University of Alberta Hospital, Edmonton, Canada

  • Vasco Salgado, MD · Hospital Professor Doutor Fernando Fonseca, EPE, Amadora, Portugal

  • Philippe Lyrer, Prof. Dr. · Universitätsspital Basel, Neurologie, Basel, Switzerland

  • Tobien Schreuder, MD · Atrium MC Parkstad, Heerlen, Netherlands

  • Maria S Rocha, MD · Hospital Santa Marcelina, Sao Paulo, Brasil

  • Hugues Chabriat, Prof. · Hôpital Lariboisière - Service Neurologie, Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States
  • Austria
  • Brazil
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

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 NCT00893867 on ClinicalTrials.gov