Treatment With AX200 for Acute Ischemic Stroke

This study has been completed.
Sponsor:
Information provided by:
Axaron Bioscience AG
ClinicalTrials.gov Identifier:
NCT00132470
First received: August 18, 2005
Last updated: July 23, 2007
Last verified: July 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: AXIS IIa - Treatment With AX200 for Acute Ischemic Stroke

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

Publications:
Additional 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
Study First Received: August 18, 2005
Last Updated: July 23, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on August 28, 2014