AXIS 2: AX200 for the Treatment of Ischemic Stroke - Full Text View

Sponsor:	Sygnis Bioscience GmbH & Co KG
Information provided by (Responsible Party):	Sygnis Bioscience GmbH & Co KG
ClinicalTrials.gov Identifier:	NCT00927836

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 II

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:

Drug Information available for: Chlorides Filgrastim Lenograstim Granulocyte colony-stimulating factor Sodium chloride

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 February 02, 2012