NDLI: Granulocyte colony-stimulating factor in patients with acute ischemic stroke: results of the AX200 for Ischemic Stroke trial.

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Granulocyte colony-stimulating factor in patients with acute ischemic stroke: results of the AX200 for Ischemic Stroke trial.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Schwab, Stefan Chamorro, Angel Schäbitz, Wolf R. Skoloudik, David Serena Leal, Joaquin Aichner, Franz Thijs, Vincent Kollmar, Rainer Rathgeb, Frank Norrving, Bo Charissé, Gabriele Vogt, Gerhard Schneider, Armin Köhrmann, Martin Gruber, Franz Laage, Rico Ringelstein, E. Bernd Saver, Jeff Fiebach, Jochen B. Veltkamp, Roland Grond, Martin Fisher, Marc Berrouschot, Jörg Brozman, Miroslav
Description	Author Affiliation: Ringelstein EB ( From the Department of Neurology, University of Münster, Münster, Germany (E.B.R.))
Abstract	BACKGROUND AND PURPOSE: Granulocyte colony-stimulating factor (G-CSF; AX200; Filgrastim) is a stroke drug candidate with excellent preclinical evidence for efficacy. A previous phase IIa dose-escalation study suggested potential efficacy in humans. The present large phase IIb trial was powered to detect clinical efficacy in acute ischemic stroke patients. METHODS: G-CSF (135 µg/kg body weight intravenous over 72 hours) was tested against placebo in 328 patients in a multinational, multicenter, randomized, and placebo-controlled trial (NCT00927836; www.clinicaltrial.gov). Main inclusion criteria were ≤9-hour time window after stroke onset, infarct localization in the middle cerebral artery territory, baseline National Institutes of Health Stroke Scale score range of 6 to 22, and baseline diffusion-weighted imaging lesion size ≥15 mL. Primary and secondary end points were the modified Rankin scale score and the National Institutes of Health Stroke Scale score at day 90, respectively. Data were analyzed using a prespecified model that adjusted for age, National Institutes of Health Stroke Scale score at baseline, and initial infarct volume (diffusion-weighted imaging). RESULTS: G-CSF treatment failed to meet the primary and secondary end points of the trial. For additional end points such as mortality, Barthel index, or infarct size at day 30, G-CSF did not show efficacy either. There was, however, a trend for reduced infarct growth in the G-CSF group. G-CSF showed the expected peripheral pharmacokinetic and pharmacodynamic profiles, with a strong increase in leukocytes and monocytes. In parallel, the cytokine profile showed a significant decrease of interleukin-1. CONCLUSIONS: G-CSF, a novel and promising drug candidate with a comprehensive preclinical and clinical package, did not provide any significant benefit with respect to either clinical outcome or imaging biomarkers. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00927836.
ISSN	00392499
e-ISSN	15244628
Journal	Stroke
Issue Number	10
Volume Number	44
Language	English
Publisher	Lippincott Williams & Wilkins (on behalf of the American Heart Association)
Publisher Date	2013-10-01
Publisher Place	United States
Access Restriction	Open
Subject Keyword	Brain Infarction Granulocyte Colony-stimulating Factor Stroke Adolescent Drug Therapy Metabolism Diffusion Magnetic Resonance Imaging Filgrastim Administration & Dosage Adverse Effects Pharmacokinetics Radiography Recombinant Proteins Time Factors Clinical Trial, Phase Ii Randomized Controlled Trial Research Support, Non-u.s. Gov't Discipline Cardiology
Content Type	Text
Resource Type	Article
Subject	Cardiology and Cardiovascular Medicine Neuroscience Advanced and Specialized Nursing Neurology (clinical)

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