We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment With AX200 for Acute Ischemic Stroke

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00132470
First Posted: August 22, 2005
Last Update Posted: July 25, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Axaron Bioscience AG
  Purpose
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.

Condition Intervention Phase
Cerebral Stroke Drug: AX200 (G-CSF) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: AXIS IIa - Treatment With AX200 for Acute Ischemic Stroke

Further study details as provided by Axaron Bioscience AG:

Primary Outcome Measures:
  • Safety

Secondary Outcome Measures:
  • Neurological outcome
  • ischemic lesion growth

Estimated Enrollment: 42
Study Start Date: December 2004
Estimated Study Completion Date: March 2007
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132470


Locations
Germany
Neurology University of Heidelberg
Heidelberg, Germany, 69120
Neurology University of Muenster
Muenster, Germany, 48149
Sponsors and Collaborators
Axaron Bioscience AG
Investigators
Principal Investigator: Wolf-Rüdiger Schäbitz, MD University of Muenster
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00132470     History of Changes
Other Study ID Numbers: AX200_P2A_1
First Submitted: August 18, 2005
First Posted: August 22, 2005
Last Update Posted: July 25, 2007
Last Verified: July 2007

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases