Back to resultsTreatment With AX200 for Acute Ischemic Stroke
Primary Purpose
Cerebral Stroke
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
AX200 (G-CSF)
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Stroke
Eligibility 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
Sites / Locations
- Neurology University of Heidelberg
- Neurology University of Muenster
Outcomes
Primary Outcome Measures
Safety
Secondary Outcome Measures
Neurological outcome
ischemic lesion growth
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00132470
Brief Title
Treatment With AX200 for Acute Ischemic Stroke
Official Title
AXIS IIa - Treatment With AX200 for Acute Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Axaron Bioscience AG
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
42 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AX200 (G-CSF)
Primary Outcome Measure Information:
Title
Safety
Secondary Outcome Measure Information:
Title
Neurological outcome
Title
ischemic lesion growth
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolf-Rüdiger Schäbitz, MD
Organizational Affiliation
University of Muenster
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurology University of Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Neurology University of Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
16007267
Citation
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.
Results Reference
background
PubMed Identifier
20947859
Citation
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.
Results Reference
derived
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Treatment With AX200 for Acute Ischemic Stroke
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