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Treatment With AX200 for Acute Ischemic Stroke

This study has been completed.
Information provided by:
Axaron Bioscience AG Identifier:
First received: August 18, 2005
Last updated: July 23, 2007
Last verified: July 2007
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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00132470     History of Changes
Other Study ID Numbers: AX200_P2A_1
Study First Received: August 18, 2005
Last Updated: July 23, 2007

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on September 19, 2017