Trial | NCT00927836  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    328
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.
Study Started
May 31
2009
Primary Completion
Nov 30
2011
Study Completion
Nov 30
2011
Last Update
Dec 13
2011
Estimate

Biological Filgrastim

135 μg/kg body weight total dose Short term infusion (20 to 30 minutes) and continuous infusion over 3 days

Drug Sodium chloride solution

Short term infusion (20 to 30 minutes) and continuous infusion over 3 days

AX200 Experimental

Placebo Placebo Comparator

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
No Results Posted