Acute Ischemic Stroke
Conditions
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.
Interventions
BIOLOGICALFilgrastim
135 μg/kg body weight total dose Short term infusion (20 to 30 minutes) and continuous infusion over 3 days
Short term infusion (20 to 30 minutes) and continuous infusion over 3 days
Sponsors
Sygnis Bioscience GmbH & Co KG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Major 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement on mRS relative to placebo-treated patients | day 90 |
Secondary
| Measure | Time frame |
|---|---|
| Improvement on NIHSS relative to placebo-treated patients | day 90 |
Countries
Austria, Belgium, Czechia, Germany, Poland, Slovakia, Spain
Outcome results
None listed