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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Biological: Filgrastim Drug: Sodium chloride solution Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 328 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : May 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011
Arms and Interventions
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Arm Intervention/treatment
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


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

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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00927836


Locations
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Sponsors and Collaborators
Sygnis Bioscience GmbH & Co KG
Investigators
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Study Chair: Frank Rathgeb, Dr. Sygnis Bioscience GmbH & Co KG
Study Director: Rico Laage, Dr. Sygnis Bioscience GmbH & Co KG
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sygnis Bioscience GmbH & Co KG
ClinicalTrials.gov Identifier: NCT00927836    
Other Study ID Numbers: AX200-101
EudraCT 2008-006444-19
First Posted: June 25, 2009    Key Record Dates
Last Update Posted: December 13, 2011
Last Verified: August 2011
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
 Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs