We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Treatment With AX200 for Acute Ischemic Stroke

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.
ClinicalTrials.gov Identifier: NCT00132470
Recruitment Status : Completed
First Posted : August 22, 2005
Last Update Posted : July 25, 2007
Information provided by:
Axaron Bioscience AG

Brief Summary:
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 or disease Intervention/treatment Phase
Cerebral Stroke Drug: AX200 (G-CSF) Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: AXIS IIa - Treatment With AX200 for Acute Ischemic Stroke
Study Start Date : December 2004
Estimated Study Completion Date : March 2007

Primary Outcome Measures :
  1. Safety

Secondary Outcome Measures :
  1. Neurological outcome
  2. ischemic lesion growth

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

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

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

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