AXIS 2: AX200 for the Treatment of Ischemic Stroke
- Conditions
- Acute Ischemic Stroke
- Interventions
- Biological: Filgrastim
- Registration Number
- NCT00927836
- Lead Sponsor
- Sygnis Bioscience GmbH & Co KG
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 328
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AX200 Filgrastim - Placebo Sodium chloride solution -
- Primary Outcome Measures
Name Time Method Improvement on mRS relative to placebo-treated patients day 90
- Secondary Outcome Measures
Name Time Method Improvement on NIHSS relative to placebo-treated patients day 90
Trial Locations
- Locations (56)
Cliniques Universitaires Saint-Luc
🇧🇪Bruxelles, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Faculty Hospital 1
🇨🇿Plzeň - Lochotín, Czech Republic
Faculty Hospital Ostrava
🇨🇿Ostrava, Czech Republic
General Faculty Hospital
🇨🇿Praha, Czech Republic
Evangelisches Krankenhaus Bielefeld
🇩🇪Bielefeld, Germany
Klinik für Neurologie Chemnitz
🇩🇪Chemnitz, Germany
Marienhospital Düsseldorf
🇩🇪Düsseldorf, Germany
Friedrich-Schiller-Universitätsklinikum
🇩🇪Jena, Germany
Universitätsklinikum Leipzig
🇩🇪Leipzig, Germany
Charité Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Klinika Neurologii z Pododdziałem Udarowym
🇵🇱Białystok, Poland
Universität Erlangen-Nürnberg
🇩🇪Erlangen, Germany
Landes-Nervenklinik Wagner-Jauregg
🇦🇹Linz, Austria
AHK Linz
🇦🇹Linz, Austria
UZ Gasthuisberg
🇧🇪Leuven, Belgium
Faculty Hospital Motol
🇨🇿Praha, Czech Republic
Kreiskrankenhaus Altenburg gGmbH
🇩🇪Altenburg, Germany
Universitätsklinikum der RWTH Aachen
🇩🇪Aachen, Germany
Berufsgenossenschaftliche Kliniken Bergmannstrost
🇩🇪Halle (Saale), Germany
Charite Universitätsklinikum "Benjamin Franklin" Klinik und Poliklinik für Neurologie
🇩🇪Berlin, Germany
Klinikum Bremen-Mitte gGmbH
🇩🇪Bremen, Germany
Universitätsklinikum Essen
🇩🇪Essen, Germany
Klinikum der Stadt Ludwigshafen
🇩🇪Ludwigshafen, Germany
Philipps-Universität Marburg
🇩🇪Marburg, Germany
Klinikum Osnabrück GmbH
🇩🇪Osnabrück, Germany
Asklepios Fachklinikum Teupitz
🇩🇪Teupitz, Germany
Neurologische Klinik, Eberhard-Karls-Universität Tübingen
🇩🇪Tübingen, Germany
Technische Universität München Klinikum rechts der Isar
🇩🇪München, Germany
II Klinika Neurologii
🇵🇱Warszawa, Poland
Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Łodzi, Centralny Szpital Weteranów, Klinika neurologii i epileptologii z oddziałem udarowym
🇵🇱Łódź, Poland
4. Faculty Hospital with Policlinic
🇸🇰Bratislava, Slovakia
Hospital de la Princesa
🇪🇸Madrid, Spain
Hopsital Univ. La Paz / Fundacion para la Investigacion
🇪🇸Madrid, Spain
Fakultna nemocnica Trnava
🇸🇰Trnava, Slovakia
Hospital Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Hospital Clínico Universitario
🇪🇸Valencia, Spain
Hospital Ramon y Cajal / Fundacion para le Investigacion Biomedica del Hospital Ramon y Cajal
🇪🇸Madrid, Spain
St. Anne's Faculty Hospital
🇨🇿Brno, Czech Republic
Faculty Hospital L. Derer
🇸🇰Bratislava, Slovakia
Faculty Hospital Nitra
🇸🇰Nitra, Slovakia
Hospital Dr. Josep Trueta
🇪🇸Girona, Spain
Hospital Univ. Virgen del Rocio
🇪🇸Sevilla, Spain
Wilhelminenspital
🇦🇹Wien, Austria
Faculty Hospital
🇸🇰Martin, Slovakia
AZ Sint-Jan AV
🇧🇪Brugge, Belgium
Municipal Hospital Ostrava
🇨🇿Ostrava, Czech Republic
Neurologische Universitätsklinik Freiburg
🇩🇪Freiburg, Germany
Universität Heidelberg
🇩🇪Heidelberg, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Wojewódzki Szpital Specjalistyczny im. Mikołaja Kopernika w Gdańsku, Oddział Neurologiczny i Leczenia Udarów Mózgu
🇵🇱Gdańsk, Poland
Instytut Psychiatrii i Neurologii, I Klinika neurologii
🇵🇱Warszawa, Poland
Comenius University Bratislava
🇸🇰Bratislava, Slovakia
Universitätsklinik Hamburg Eppendorf
🇩🇪Hamburg, Germany