Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

AXIS 2: AX200 for the Treatment of Ischemic Stroke (AXIS-2)

This study has been completed.
Information provided by (Responsible Party):
Sygnis Bioscience GmbH & Co KG Identifier:
First received: June 24, 2009
Last updated: December 12, 2011
Last verified: August 2011
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.

Condition Intervention Phase
Acute Ischemic Stroke
Biological: Filgrastim
Drug: Sodium chloride solution
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: AXIS 2: AX200 for the Treatment of Ischemic Stroke - A Multinational, Multicenter, Randomized, Doubleblind, Placebo-controlled Phase II Trial

Further study details as provided by Sygnis Bioscience GmbH & Co KG:

Primary Outcome Measures:
  • Improvement on mRS relative to placebo-treated patients [ Time Frame: day 90 ]

Secondary Outcome Measures:
  • Improvement on NIHSS relative to placebo-treated patients [ Time Frame: day 90 ]

Enrollment: 328
Study Start Date: May 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AX200 Biological: Filgrastim
135 μg/kg body weight total dose Short term infusion (20 to 30 minutes) and continuous infusion over 3 days
Placebo Comparator: Placebo Drug: Sodium chloride solution
Short term infusion (20 to 30 minutes) and continuous infusion over 3 days


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00927836

  Show 58 Study Locations
Sponsors and Collaborators
Sygnis Bioscience GmbH & Co KG
Study Chair: Frank Rathgeb, Dr. Sygnis Bioscience GmbH & Co KG
Study Director: Rico Laage, Dr. Sygnis Bioscience GmbH & Co KG
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sygnis Bioscience GmbH & Co KG Identifier: NCT00927836     History of Changes
Other Study ID Numbers: AX200-101
EudraCT 2008-006444-19
Study First Received: June 24, 2009
Last Updated: December 12, 2011

Additional relevant MeSH terms:
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia processed this record on May 25, 2017