Treatment With AX200 for Acute Ischemic Stroke
AXIS IIa - Treatment With AX200 for Acute Ischemic Stroke
1 other identifier
interventional
42
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2004
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 18, 2005
CompletedFirst Posted
Study publicly available on registry
August 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedJuly 25, 2007
July 1, 2007
August 18, 2005
July 23, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
Safety
Secondary Outcomes (2)
Neurological outcome
ischemic lesion growth
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Time interval since stroke onset impossible to determine
- Carotid T-occlusion (magnetic resonance angiography \[MRA\])
- Subarachnoid hemorrhages
- Several safety parameters
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Neurology University of Heidelberg
Heidelberg, 69120, Germany
Neurology University of Muenster
Münster, 48149, Germany
Related Publications (2)
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.
PMID: 16007267BACKGROUNDSchabitz 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.
PMID: 20947859DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wolf-Rüdiger Schäbitz, MD
Universität Münster
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 18, 2005
First Posted
August 22, 2005
Study Start
December 1, 2004
Study Completion
March 1, 2007
Last Updated
July 25, 2007
Record last verified: 2007-07