Treatment With AX200 for Acute Ischemic Stroke

This study has been completed.

First Received: August 18, 2005 Last Updated: July 23, 2007 History of Changes

Sponsor:	Axaron Bioscience AG
Information provided by:	Axaron Bioscience AG
ClinicalTrials.gov Identifier:	NCT00132470

Purpose

The AXIS study is a randomized, double-blind, placebo-controlled, dose-escalating phase IIa trial to investigate treatment with AX200 (granulocyte-colony stimulating factor; G-CSF) for acute ischemic stroke. The primary objective of the present phase IIa study is to assess the safety and tolerability of AX200 compared to placebo in subjects suffering from acute stroke. The secondary objective is to assess the effect of AX200 on subject outcome in comparison to placebo.

Condition	Intervention	Phase
Cerebral Stroke	Drug: AX200 (G-CSF)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	AXIS IIa - Treatment With AX200 for Acute Ischemic Stroke

Further study details as provided by Axaron Bioscience AG:

Primary Outcome Measures:

Safety

Secondary Outcome Measures:

Neurological outcome
ischemic lesion growth

Estimated Enrollment:	42
Study Start Date:	December 2004
Estimated Study Completion Date:	March 2007

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Stroke onset within 12 hours prior to start of study agent administration
Ischemic stroke in the middle cerebral artery (MCA) territory confirmed by magnetic resonance imaging (MRI)

Exclusion Criteria:

Time interval since stroke onset impossible to determine
Carotid T-occlusion (magnetic resonance angiography [MRA])
Subarachnoid hemorrhages
Several safety parameters

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132470

Locations

Germany
Neurology University of Muenster
Muenster, Germany, 48149
Neurology University of Heidelberg
Heidelberg, Germany, 69120

Sponsors and Collaborators

Axaron Bioscience AG

Investigators

Principal Investigator:

Wolf-Rüdiger Schäbitz, MD

University of Muenster

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Schneider A, Kruger C, Steigleder T, Weber D, Pitzer C, Laage R, Aronowski J, Maurer MH, Gassler N, Mier W, Hasselblatt M, Kollmar R, Schwab S, Sommer C, Bach A, Kuhn HG, Schabitz WR. The hematopoietic factor G-CSF is a neuronal ligand that counteracts programmed cell death and drives neurogenesis. J Clin Invest. 2005 Aug 1;115(8):2083-2098. Epub 2005 Jul 7.

Study ID Numbers:	AX200_P2A_1
Study First Received:	August 18, 2005
Last Updated:	July 23, 2007
ClinicalTrials.gov Identifier:	NCT00132470 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Cerebral Infarction
Nervous System Diseases
Stroke
Vascular Diseases
Brain Ischemia

Central Nervous System Diseases
Cardiovascular Diseases
Brain Infarction
Brain Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on February 08, 2010