Clinical trial NCT00927836: AXIS 2: AX200 for the Treatment of Ischemic Stroke
Official title: AXIS 2: AX200 for the Treatment of Ischemic Stroke - A Multinational, Multicenter, Randomized, Doubleblind, Placebo-controlled Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Ischemic Stroke
Lead sponsor: Sygnis Bioscience GmbH & Co KG
Sponsor class: INDUSTRY
First posted: 2009-06-25
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Major Inclusion Criteria:

* 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 Exclusion Criteria:

* 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

Primary outcomes:
measure: Improvement on mRS relative to placebo-treated patients
timeFrame: day 90
Secondary outcomes:
measure: Improvement on NIHSS relative to placebo-treated patients
timeFrame: day 90
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Landes-Nervenklinik Wagner-Jauregg
city: Linz
country: Austria
facility: AHK Linz
city: Wien
country: Austria
facility: Wilhelminenspital
city: Brugge
country: Belgium
facility: AZ Sint-Jan AV
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Brno
country: Czech Republic
facility: St. Anne's Faculty Hospital
city: Olomouc
country: Czech Republic
facility: Faculty Hospital
city: Ostrava
country: Czech Republic
facility: Faculty Hospital Ostrava
city: Ostrava
country: Czech Republic
facility: Municipal Hospital Ostrava
city: Plzeň - Lochotín
country: Czech Republic
facility: Faculty Hospital 1
city: Praha
country: Czech Republic
facility: General Faculty Hospital
city: Praha
country: Czech Republic
facility: Faculty Hospital Motol
city: Aachen
country: Germany
facility: Universitätsklinikum der RWTH Aachen
city: Altenburg
country: Germany
facility: Kreiskrankenhaus Altenburg gGmbH
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Charite Universitätsklinikum "Benjamin Franklin" Klinik und Poliklinik für Neurologie
city: Bielefeld
country: Germany
facility: Evangelisches Krankenhaus Bielefeld
city: Bremen
country: Germany
facility: Klinikum Bremen-Mitte gGmbH
city: Chemnitz
country: Germany
facility: Klinik für Neurologie Chemnitz
city: Düsseldorf
country: Germany
facility: Marienhospital Düsseldorf
city: Erlangen
country: Germany
facility: Universität Erlangen-Nürnberg
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Freiburg
country: Germany
facility: Neurologische Universitätsklinik Freiburg
city: Halle (Saale)
country: Germany
facility: Berufsgenossenschaftliche Kliniken Bergmannstrost
city: Hamburg
country: Germany
facility: Universitätsklinik Hamburg Eppendorf
city: Heidelberg
country: Germany
facility: Universität Heidelberg
city: Jena
country: Germany
facility: Friedrich-Schiller-Universitätsklinikum
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen
city: Marburg
country: Germany
facility: Philipps-Universität Marburg
city: München
country: Germany
facility: Technische Universität München Klinikum rechts der Isar
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Osnabrück
country: Germany
facility: Klinikum Osnabrück GmbH
city: Teupitz
country: Germany
facility: Asklepios Fachklinikum Teupitz
city: Tübingen
country: Germany
facility: Neurologische Klinik, Eberhard-Karls-Universität Tübingen
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Białystok
country: Poland
facility: Klinika Neurologii z Pododdziałem Udarowym
city: Gdańsk
country: Poland
facility: Wojewódzki Szpital Specjalistyczny im. Mikołaja Kopernika w Gdańsku, Oddział Neurologiczny i Leczenia Udarów Mózgu
city: Warszawa
country: Poland
facility: II Klinika Neurologii
city: Warszawa
country: Poland
facility: Instytut Psychiatrii i Neurologii, I Klinika neurologii
city: Łódź
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Łodzi, Centralny Szpital Weteranów, Klinika neurologii i epileptologii z oddziałem udarowym
city: Bratislava
country: Slovakia
facility: Comenius University Bratislava
city: Bratislava
country: Slovakia
facility: 4. Faculty Hospital with Policlinic
city: Bratislava
country: Slovakia
facility: Faculty Hospital L. Derer
city: Košice
country: Slovakia
facility: Faculty Hospital
city: Martin
country: Slovakia
facility: Faculty Hospital
city: Nitra
country: Slovakia
facility: Faculty Hospital Nitra
city: Trnava
country: Slovakia
facility: Fakultna nemocnica Trnava
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Girona
country: Spain
facility: Hospital Dr. Josep Trueta
city: Madrid
country: Spain
facility: Hospital de la Princesa
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal / Fundacion para le Investigacion Biomedica del Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Hopsital Univ. La Paz / Fundacion para la Investigacion
city: Sevilla
country: Spain
facility: Hospital Univ. Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Clínico Universitario
Study officials:
affiliation: Sygnis Bioscience GmbH & Co KG
name: Frank Rathgeb, Dr.
role: STUDY_CHAIR
affiliation: Sygnis Bioscience GmbH & Co KG
name: Rico Laage, Dr.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.