AXIS 2: AX200 for the Treatment of Ischemic Stroke
Phase 2
Completed
- Conditions
- Acute Ischemic Stroke
- Interventions
- Biological: Filgrastim
- Registration Number
- NCT00927836
- Lead Sponsor
- Sygnis Bioscience GmbH & Co KG
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 328
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AX200 Filgrastim - Placebo Sodium chloride solution -
- Primary Outcome Measures
Name Time Method Improvement on mRS relative to placebo-treated patients day 90
- Secondary Outcome Measures
Name Time Method Improvement on NIHSS relative to placebo-treated patients day 90
Trial Locations
- Locations (56)
Landes-Nervenklinik Wagner-Jauregg
🇦🇹Linz, Austria
AHK Linz
🇦🇹Linz, Austria
Wilhelminenspital
🇦🇹Wien, Austria
AZ Sint-Jan AV
🇧🇪Brugge, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Bruxelles, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
UZ Gasthuisberg
🇧🇪Leuven, Belgium
St. Anne's Faculty Hospital
🇨🇿Brno, Czech Republic
Faculty Hospital
🇸🇰Martin, Slovakia
Faculty Hospital Ostrava
🇨🇿Ostrava, Czech Republic
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