AXIS 2: AX200 for the Treatment of Ischemic Stroke
AXIS-2
2 other identifiers
interventional
328
7 countries
58
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2009
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 24, 2009
CompletedFirst Posted
Study publicly available on registry
June 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedDecember 13, 2011
August 1, 2011
2.5 years
June 24, 2009
December 12, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement on mRS relative to placebo-treated patients
day 90
Secondary Outcomes (1)
Improvement on NIHSS relative to placebo-treated patients
day 90
Study Arms (2)
AX200
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
135 μg/kg body weight total dose Short term infusion (20 to 30 minutes) and continuous infusion over 3 days
Short term infusion (20 to 30 minutes) and continuous infusion over 3 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
Landes-Nervenklinik Wagner-Jauregg
Linz, 4020, Austria
AHK Linz
Linz, 4021, Austria
Wilhelminenspital
Vienna, 1160, Austria
AZ Sint-Jan AV
Bruges, 8000, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
UZ Gasthuisberg
Leuven, 3000, Belgium
St. Anne's Faculty Hospital
Brno, 656 91, Czechia
Faculty Hospital
Olomouc, 775 20, Czechia
Faculty Hospital Ostrava
Ostrava, 708 52, Czechia
Municipal Hospital Ostrava
Ostrava, 728 80, Czechia
Faculty Hospital 1
Plzeň - Lochotín, 304 60, Czechia
General Faculty Hospital
Prague, 120 00, Czechia
Faculty Hospital Motol
Prague, 150 06, Czechia
Universitätsklinikum der RWTH Aachen
Aachen, 52074, Germany
Kreiskrankenhaus Altenburg gGmbH
Altenburg, 04600, Germany
Charité Universitätsmedizin Berlin
Berlin, 10117, Germany
Charite Universitätsklinikum "Benjamin Franklin" Klinik und Poliklinik für Neurologie
Berlin, 12200, Germany
Evangelisches Krankenhaus Bielefeld
Bielefeld, 33617, Germany
Klinikum Bremen-Mitte gGmbH
Bremen, 28177, Germany
Klinik für Neurologie Chemnitz
Chemnitz, 09131, Germany
Marienhospital Düsseldorf
Düsseldorf, 40479, Germany
Universität Erlangen-Nürnberg
Erlangen, 91054, Germany
Universitätsklinikum Essen
Essen, 45122, Germany
Neurologische Universitätsklinik Freiburg
Freiburg im Breisgau, 79106, Germany
Berufsgenossenschaftliche Kliniken Bergmannstrost
Halle, 06112, Germany
Universitätsklinik Hamburg Eppendorf
Hamburg, 20246, Germany
Universität Heidelberg
Heidelberg, 69120, Germany
Friedrich-Schiller-Universitätsklinikum
Jena, 07747, Germany
Universitätsklinikum Leipzig
Leipzig, 04103, Germany
Klinikum der Stadt Ludwigshafen
Ludwigshafen, 67063, Germany
Philipps-Universität Marburg
Marburg, 35039, Germany
Technische Universität München Klinikum rechts der Isar
München, 81675, Germany
Universitätsklinikum Münster
Münster, 48149, Germany
Klinikum Osnabrück GmbH
Osnabrück, 49076, Germany
Asklepios Fachklinikum Teupitz
Teupitz, 15755, Germany
Neurologische Klinik, Eberhard-Karls-Universität Tübingen
Tübingen, 72076, Germany
Universitätsklinikum Ulm
Ulm, 89081, Germany
Klinika Neurologii z Pododdziałem Udarowym
Bialystok, 15-276, Poland
Wojewódzki Szpital Specjalistyczny im. Mikołaja Kopernika w Gdańsku, Oddział Neurologiczny i Leczenia Udarów Mózgu
Gdansk, 80-803, Poland
Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Łodzi, Centralny Szpital Weteranów, Klinika neurologii i epileptologii z oddziałem udarowym
Lodz, 90-549, Poland
II Klinika Neurologii
Warsaw, 02-957, Poland
Instytut Psychiatrii i Neurologii, I Klinika neurologii
Warsaw, 02-957, Poland
Comenius University Bratislava
Bratislava, 813 69, Slovakia
4. Faculty Hospital with Policlinic
Bratislava, 826 06, Slovakia
Faculty Hospital L. Derer
Bratislava, 833 05, Slovakia
Faculty Hospital
Košice, 041 66, Slovakia
Faculty Hospital
Martin, 036 59, Slovakia
Faculty Hospital Nitra
Nitra, 949 01, Slovakia
Fakultna nemocnica Trnava
Trnava, 917 75, Slovakia
Hospital Santa Creu i Sant Pau
Barcelona, 08025, Spain
Hospital Clínic de Barcelona
Barcelona, 08036, Spain
Hospital Dr. Josep Trueta
Girona, 17017, Spain
Hospital de la Princesa
Madrid, 28006, Spain
Hospital Ramon y Cajal / Fundacion para le Investigacion Biomedica del Hospital Ramon y Cajal
Madrid, 28034, Spain
Hopsital Univ. La Paz / Fundacion para la Investigacion
Madrid, 28046, Spain
Hospital Univ. Virgen del Rocio
Seville, 41013, Spain
Hospital Clínico Universitario
Valencia, 46010, Spain
Related Publications (4)
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.
PMID: 33980046DERIVEDBu 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.
PMID: 33504185DERIVEDKufner 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.
PMID: 25765724DERIVEDRingelstein 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.
PMID: 23963331DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Frank Rathgeb, Dr.
Sygnis Bioscience GmbH & Co KG
- STUDY DIRECTOR
Rico Laage, Dr.
Sygnis Bioscience GmbH & Co KG
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2009
First Posted
June 25, 2009
Study Start
May 1, 2009
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
December 13, 2011
Record last verified: 2011-08