Treatment With AX200 for Acute Ischemic Stroke

July 23, 2007 updated by: Axaron Bioscience AG

AXIS IIa - Treatment With AX200 for Acute Ischemic Stroke

The AXIS study is a randomized, double-blind, placebo-controlled, dose-escalating phase IIa trial to investigate treatment with AX200 (granulocyte-colony stimulating factor; G-CSF) for acute ischemic stroke. The primary objective of the present phase IIa study is to assess the safety and tolerability of AX200 compared to placebo in subjects suffering from acute stroke. The secondary objective is to assess the effect of AX200 on subject outcome in comparison to placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • Neurology University of Heidelberg
      • Muenster, Germany, 48149
        • Neurology University of Muenster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stroke onset within 12 hours prior to start of study agent administration
  • Ischemic stroke in the middle cerebral artery (MCA) territory confirmed by magnetic resonance imaging (MRI)

Exclusion Criteria:

  • Time interval since stroke onset impossible to determine
  • Carotid T-occlusion (magnetic resonance angiography [MRA])
  • Subarachnoid hemorrhages
  • Several safety parameters

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety

Secondary Outcome Measures

Outcome Measure
Neurological outcome
ischemic lesion growth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axaron Bioscience AG

Investigators

  • Principal Investigator: Wolf-Rüdiger Schäbitz, MD, University of Muenster

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Study Completion

March 1, 2007

Study Registration Dates

First Submitted

August 18, 2005

First Submitted That Met QC Criteria

August 18, 2005

First Posted (Estimate)

August 22, 2005

Study Record Updates

Last Update Posted (Estimate)

July 25, 2007

Last Update Submitted That Met QC Criteria

July 23, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AX200_P2A_1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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