Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
328 participants
INTERVENTIONAL
2009-05-31
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AX200
Filgrastim
135 μg/kg body weight total dose Short term infusion (20 to 30 minutes) and continuous infusion over 3 days
Placebo
Sodium chloride solution
Short term infusion (20 to 30 minutes) and continuous infusion over 3 days
Interventions
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Filgrastim
135 μg/kg body weight total dose Short term infusion (20 to 30 minutes) and continuous infusion over 3 days
Sodium chloride solution
Short term infusion (20 to 30 minutes) and continuous infusion over 3 days
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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Sygnis Bioscience GmbH & Co KG
INDUSTRY
Responsible Party
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Principal Investigators
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Frank Rathgeb, Dr.
Role: STUDY_CHAIR
Sygnis Bioscience GmbH & Co KG
Rico Laage, Dr.
Role: STUDY_DIRECTOR
Sygnis Bioscience GmbH & Co KG
Locations
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Landes-Nervenklinik Wagner-Jauregg
Linz, , Austria
AHK Linz
Linz, , Austria
Wilhelminenspital
Vienna, , Austria
AZ Sint-Jan AV
Bruges, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
UZ Gasthuisberg
Leuven, , Belgium
St. Anne's Faculty Hospital
Brno, , Czechia
Faculty Hospital
Olomouc, , Czechia
Faculty Hospital Ostrava
Ostrava, , Czechia
Municipal Hospital Ostrava
Ostrava, , Czechia
Faculty Hospital 1
Plzeň - Lochotín, , Czechia
General Faculty Hospital
Prague, , Czechia
Faculty Hospital Motol
Prague, , Czechia
Universitätsklinikum der RWTH Aachen
Aachen, , Germany
Kreiskrankenhaus Altenburg gGmbH
Altenburg, , Germany
Charité Universitätsmedizin Berlin
Berlin, , Germany
Charite Universitätsklinikum "Benjamin Franklin" Klinik und Poliklinik für Neurologie
Berlin, , Germany
Evangelisches Krankenhaus Bielefeld
Bielefeld, , Germany
Klinikum Bremen-Mitte gGmbH
Bremen, , Germany
Klinik für Neurologie Chemnitz
Chemnitz, , Germany
Marienhospital Düsseldorf
Düsseldorf, , Germany
Universität Erlangen-Nürnberg
Erlangen, , Germany
Universitätsklinikum Essen
Essen, , Germany
Neurologische Universitätsklinik Freiburg
Freiburg im Breisgau, , Germany
Berufsgenossenschaftliche Kliniken Bergmannstrost
Halle, , Germany
Universitätsklinik Hamburg Eppendorf
Hamburg, , Germany
Universität Heidelberg
Heidelberg, , Germany
Friedrich-Schiller-Universitätsklinikum
Jena, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
Klinikum der Stadt Ludwigshafen
Ludwigshafen, , Germany
Philipps-Universität Marburg
Marburg, , Germany
Technische Universität München Klinikum rechts der Isar
München, , Germany
Universitätsklinikum Münster
Münster, , Germany
Klinikum Osnabrück GmbH
Osnabrück, , Germany
Asklepios Fachklinikum Teupitz
Teupitz, , Germany
Neurologische Klinik, Eberhard-Karls-Universität Tübingen
Tübingen, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Klinika Neurologii z Pododdziałem Udarowym
Bialystok, , Poland
Wojewódzki Szpital Specjalistyczny im. Mikołaja Kopernika w Gdańsku, Oddział Neurologiczny i Leczenia Udarów Mózgu
Gdansk, , Poland
Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Łodzi, Centralny Szpital Weteranów, Klinika neurologii i epileptologii z oddziałem udarowym
Lodz, , Poland
II Klinika Neurologii
Warsaw, , Poland
Instytut Psychiatrii i Neurologii, I Klinika neurologii
Warsaw, , Poland
Comenius University Bratislava
Bratislava, , Slovakia
4. Faculty Hospital with Policlinic
Bratislava, , Slovakia
Faculty Hospital L. Derer
Bratislava, , Slovakia
Faculty Hospital
Košice, , Slovakia
Faculty Hospital
Martin, , Slovakia
Faculty Hospital Nitra
Nitra, , Slovakia
Fakultna nemocnica Trnava
Trnava, , Slovakia
Hospital Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital Dr. Josep Trueta
Girona, , Spain
Hospital de la Princesa
Madrid, , Spain
Hospital Ramon y Cajal / Fundacion para le Investigacion Biomedica del Hospital Ramon y Cajal
Madrid, , Spain
Hopsital Univ. La Paz / Fundacion para la Investigacion
Madrid, , Spain
Hospital Univ. Virgen del Rocio
Seville, , Spain
Hospital Clínico Universitario
Valencia, , Spain
Countries
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References
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Scheldeman L, Wouters A, Dupont P, Christensen S, Boutitie F, Cheng B, Ebinger M, Endres M, Fiebach JB, Gerloff C, Muir KW, Nighoghossian N, Pedraza S, Simonsen CZ, Ringelstein EB, Chamorro A, Grond M, Laage R, Schneider A, Thomalla G, Thijs V, Lemmens R. Reversible Edema in the Penumbra Correlates With Severity of Hypoperfusion. Stroke. 2021 Jul;52(7):2338-2346. doi: 10.1161/STROKEAHA.120.033071. Epub 2021 May 13.
Bu N, Khlif MS, Lemmens R, Wouters A, Fiebach JB, Chamorro A, Ringelstein EB, Norrving B, Laage R, Grond M, Wilms G, Brodtmann A, Thijs V. Imaging Markers of Brain Frailty and Outcome in Patients With Acute Ischemic Stroke. Stroke. 2021 Mar;52(3):1004-1011. doi: 10.1161/STROKEAHA.120.029841. Epub 2021 Jan 28.
Kufner A, Wouters A, Bracoud L, Laage R, Schneider A, Schabitz WR, Hermier M, Thijs V, Fiebach JB; AXIS2 investigators. Infarct volume-based subgroup selection in acute ischemic stroke trials. Stroke. 2015 May;46(5):1368-70. doi: 10.1161/STROKEAHA.114.008115. Epub 2015 Mar 12.
Ringelstein EB, Thijs V, Norrving B, Chamorro A, Aichner F, Grond M, Saver J, Laage R, Schneider A, Rathgeb F, Vogt G, Charisse G, Fiebach JB, Schwab S, Schabitz WR, Kollmar R, Fisher M, Brozman M, Skoloudik D, Gruber F, Serena Leal J, Veltkamp R, Kohrmann M, Berrouschot J; AXIS 2 Investigators. Granulocyte colony-stimulating factor in patients with acute ischemic stroke: results of the AX200 for Ischemic Stroke trial. Stroke. 2013 Oct;44(10):2681-7. doi: 10.1161/STROKEAHA.113.001531. Epub 2013 Aug 20.
Other Identifiers
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EudraCT 2008-006444-19
Identifier Type: -
Identifier Source: secondary_id
AX200-101
Identifier Type: -
Identifier Source: org_study_id