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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00927836
Recruitment Status : Completed
First Posted : June 25, 2009
Last Update Posted : December 13, 2011
Sponsor:
Information provided by (Responsible Party):
Sygnis Bioscience GmbH & Co KG

Tracking Information
First Submitted Date  ICMJE June 24, 2009
First Posted Date  ICMJE June 25, 2009
Last Update Posted Date December 13, 2011
Study Start Date  ICMJE May 2009
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2009)
Improvement on mRS relative to placebo-treated patients [ Time Frame: day 90 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2009)
Improvement on NIHSS relative to placebo-treated patients [ Time Frame: day 90 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AXIS 2: AX200 for the Treatment of Ischemic Stroke
Official Title  ICMJE AXIS 2: AX200 for the Treatment of Ischemic Stroke - A Multinational, Multicenter, Randomized, Doubleblind, Placebo-controlled Phase II Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Ischemic Stroke
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: AX200
    Intervention: Biological: Filgrastim
  • Placebo Comparator: Placebo
    Intervention: Drug: Sodium chloride solution
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2010)
328
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2009)
350
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Czech Republic,   Germany,   Poland,   Slovakia,   Spain
Removed Location Countries Sweden
 
Administrative Information
NCT Number  ICMJE NCT00927836
Other Study ID Numbers  ICMJE AX200-101
EudraCT 2008-006444-19
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sygnis Bioscience GmbH & Co KG
Study Sponsor  ICMJE Sygnis Bioscience GmbH & Co KG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Frank Rathgeb, Dr. Sygnis Bioscience GmbH & Co KG
Study Director: Rico Laage, Dr. Sygnis Bioscience GmbH & Co KG
PRS Account Sygnis Bioscience GmbH & Co KG
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP