Status:
COMPLETED
AXIS 2: AX200 for the Treatment of Ischemic Stroke
Lead Sponsor:
Sygnis Bioscience GmbH & Co KG
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the efficacy of AX200 (filgrastim) in the treatment of acute ischemic stroke and to assess the safety and tolerability of AX200.
Eligibility Criteria
Inclusion
- Major
- diagnosis of acute ischemic stroke with an onset within 9 hours prior to start of study agent administration
- ischemic stroke in the MCA territory confirmed by MRI (diffusion)
- age ≥18 years and ≤85 years
- lesion size on DWI ≥15 ccm
- written informed consent
- Major
Exclusion
- prior to current stroke: inability to walk or to lead an independent life
- life expectancy less or equal 6 months
- stupor or coma
- lacunar infarct
- any evidence of ICH
- malignant hypertension
- presence of history of active malignancies
- platelet count \<100/nl at randomization
- leukocyte count \>20/nl at randomization
- congenital neutropenia
- pregnant or lactating women
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT00927836
Start Date
May 1 2009
End Date
November 1 2011
Last Update
December 13 2011
Active Locations (58)
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1
Landes-Nervenklinik Wagner-Jauregg
Linz, Austria, 4020
2
AHK Linz
Linz, Austria, 4021
3
Wilhelminenspital
Vienna, Austria, 1160
4
AZ Sint-Jan AV
Bruges, Belgium, 8000