AXIS 2: AX200 for the Treatment of Ischemic Stroke
AXIS 2: AX200 for the Treatment of Ischemic Stroke - A Multinational, Multicenter, Randomized, Doubleblind, Placebo-controlled Phase II Trial
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.
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
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