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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sygnis Bioscience GmbH & Co KG
ClinicalTrials.gov Identifier:
NCT00927836
First received: June 24, 2009
Last updated: December 12, 2011
Last verified: August 2011
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement on NIHSS relative to placebo-treated patients [ Time Frame: day 90 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00927836

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

No publications provided

Responsible Party: Sygnis Bioscience GmbH & Co KG
ClinicalTrials.gov 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
Health Authority: Austria: Federal Office for Safety in Health Care
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Poland: Ministry of Health
Slovakia: State Institute for Drug Control
Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
 Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013