- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00132470
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
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
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Heidelberg, Germany, 69120
- Neurology University of Heidelberg
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Muenster, Germany, 48149
- Neurology University of Muenster
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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 |
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Safety
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Secondary Outcome Measures
Outcome Measure |
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Neurological outcome
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ischemic lesion growth
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Schneider A, Kruger C, Steigleder T, Weber D, Pitzer C, Laage R, Aronowski J, Maurer MH, Gassler N, Mier W, Hasselblatt M, Kollmar R, Schwab S, Sommer C, Bach A, Kuhn HG, Schabitz WR. The hematopoietic factor G-CSF is a neuronal ligand that counteracts programmed cell death and drives neurogenesis. J Clin Invest. 2005 Aug;115(8):2083-98. doi: 10.1172/JCI23559. Epub 2005 Jul 7.
- Schabitz WR, Laage R, Vogt G, Koch W, Kollmar R, Schwab S, Schneider D, Hamann GF, Rosenkranz M, Veltkamp R, Fiebach JB, Hacke W, Grotta JC, Fisher M, Schneider A. AXIS: a trial of intravenous granulocyte colony-stimulating factor in acute ischemic stroke. Stroke. 2010 Nov;41(11):2545-51. doi: 10.1161/STROKEAHA.110.579508. Epub 2010 Oct 14.
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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