Back to resultsAXIS 2: AX200 for the Treatment of Ischemic Stroke (AXIS-2)
Primary Purpose
Acute Ischemic Stroke
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Filgrastim
Sodium chloride solution
Sponsored by
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke
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
Sites / Locations
- Landes-Nervenklinik Wagner-Jauregg
- AHK Linz
- Wilhelminenspital
- AZ Sint-Jan AV
- Cliniques Universitaires Saint-Luc
- Universitair Ziekenhuis Gent
- UZ Gasthuisberg
- St. Anne's Faculty Hospital
- Faculty Hospital
- Faculty Hospital Ostrava
- Municipal Hospital Ostrava
- Faculty Hospital 1
- General Faculty Hospital
- Faculty Hospital Motol
- Universitätsklinikum der RWTH Aachen
- Kreiskrankenhaus Altenburg gGmbH
- Charité Universitätsmedizin Berlin
- Charite Universitätsklinikum "Benjamin Franklin" Klinik und Poliklinik für Neurologie
- Evangelisches Krankenhaus Bielefeld
- Klinikum Bremen-Mitte gGmbH
- Klinik für Neurologie Chemnitz
- Marienhospital Düsseldorf
- Universität Erlangen-Nürnberg
- Universitätsklinikum Essen
- Neurologische Universitätsklinik Freiburg
- Berufsgenossenschaftliche Kliniken Bergmannstrost
- Universitätsklinik Hamburg Eppendorf
- Universität Heidelberg
- Friedrich-Schiller-Universitätsklinikum
- Universitätsklinikum Leipzig
- Klinikum der Stadt Ludwigshafen
- Philipps-Universität Marburg
- Technische Universität München Klinikum rechts der Isar
- Universitätsklinikum Münster
- Klinikum Osnabrück GmbH
- Asklepios Fachklinikum Teupitz
- Neurologische Klinik, Eberhard-Karls-Universität Tübingen
- Universitätsklinikum Ulm
- Klinika Neurologii z Pododdziałem Udarowym
- Wojewódzki Szpital Specjalistyczny im. Mikołaja Kopernika w Gdańsku, Oddział Neurologiczny i Leczenia Udarów Mózgu
- II Klinika Neurologii
- Instytut Psychiatrii i Neurologii, I Klinika neurologii
- Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Łodzi, Centralny Szpital Weteranów, Klinika neurologii i epileptologii z oddziałem udarowym
- Comenius University Bratislava
- 4. Faculty Hospital with Policlinic
- Faculty Hospital L. Derer
- Faculty Hospital
- Faculty Hospital
- Faculty Hospital Nitra
- Fakultna nemocnica Trnava
- Hospital Santa Creu i Sant Pau
- Hospital Clínic de Barcelona
- Hospital Dr. Josep Trueta
- Hospital de la Princesa
- Hospital Ramon y Cajal / Fundacion para le Investigacion Biomedica del Hospital Ramon y Cajal
- Hopsital Univ. La Paz / Fundacion para la Investigacion
- Hospital Univ. Virgen del Rocio
- Hospital Clínico Universitario
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AX200
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Improvement on mRS relative to placebo-treated patients
Secondary Outcome Measures
Improvement on NIHSS relative to placebo-treated patients
Full Information
NCT ID
NCT00927836
First Posted
June 24, 2009
Last Updated
December 12, 2011
Sponsor
Sygnis Bioscience GmbH & Co KG
1. Study Identification
Unique Protocol Identification Number
NCT00927836
Brief Title
AXIS 2: AX200 for the Treatment of Ischemic Stroke
Acronym
AXIS-2
Official Title
AXIS 2: AX200 for the Treatment of Ischemic Stroke - A Multinational, Multicenter, Randomized, Doubleblind, Placebo-controlled Phase II Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sygnis Bioscience GmbH & Co KG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
328 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AX200
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Filgrastim
Intervention Description
135 μg/kg body weight total dose Short term infusion (20 to 30 minutes) and continuous infusion over 3 days
Intervention Type
Drug
Intervention Name(s)
Sodium chloride solution
Intervention Description
Short term infusion (20 to 30 minutes) and continuous infusion over 3 days
Primary Outcome Measure Information:
Title
Improvement on mRS relative to placebo-treated patients
Time Frame
day 90
Secondary Outcome Measure Information:
Title
Improvement on NIHSS relative to placebo-treated patients
Time Frame
day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Rathgeb, Dr.
Organizational Affiliation
Sygnis Bioscience GmbH & Co KG
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rico Laage, Dr.
Organizational Affiliation
Sygnis Bioscience GmbH & Co KG
Official's Role
Study Director
Facility Information:
Facility Name
Landes-Nervenklinik Wagner-Jauregg
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
AHK Linz
City
Linz
ZIP/Postal Code
4021
Country
Austria
Facility Name
Wilhelminenspital
City
Wien
ZIP/Postal Code
1160
Country
Austria
Facility Name
AZ Sint-Jan AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
St. Anne's Faculty Hospital
City
Brno
ZIP/Postal Code
656 91
Country
Czech Republic
Facility Name
Faculty Hospital
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Faculty Hospital Ostrava
City
Ostrava
ZIP/Postal Code
708 52
Country
Czech Republic
Facility Name
Municipal Hospital Ostrava
City
Ostrava
ZIP/Postal Code
728 80
Country
Czech Republic
Facility Name
Faculty Hospital 1
City
Plzeň - Lochotín
ZIP/Postal Code
304 60
Country
Czech Republic
Facility Name
General Faculty Hospital
City
Praha
ZIP/Postal Code
120 00
Country
Czech Republic
Facility Name
Faculty Hospital Motol
City
Praha
ZIP/Postal Code
150 06
Country
Czech Republic
Facility Name
Universitätsklinikum der RWTH Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Kreiskrankenhaus Altenburg gGmbH
City
Altenburg
ZIP/Postal Code
04600
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Charite Universitätsklinikum "Benjamin Franklin" Klinik und Poliklinik für Neurologie
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Evangelisches Krankenhaus Bielefeld
City
Bielefeld
ZIP/Postal Code
33617
Country
Germany
Facility Name
Klinikum Bremen-Mitte gGmbH
City
Bremen
ZIP/Postal Code
28177
Country
Germany
Facility Name
Klinik für Neurologie Chemnitz
City
Chemnitz
ZIP/Postal Code
09131
Country
Germany
Facility Name
Marienhospital Düsseldorf
City
Düsseldorf
ZIP/Postal Code
40479
Country
Germany
Facility Name
Universität Erlangen-Nürnberg
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Neurologische Universitätsklinik Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Berufsgenossenschaftliche Kliniken Bergmannstrost
City
Halle (Saale)
ZIP/Postal Code
06112
Country
Germany
Facility Name
Universitätsklinik Hamburg Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universität Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Friedrich-Schiller-Universitätsklinikum
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Philipps-Universität Marburg
City
Marburg
ZIP/Postal Code
35039
Country
Germany
Facility Name
Technische Universität München Klinikum rechts der Isar
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Klinikum Osnabrück GmbH
City
Osnabrück
ZIP/Postal Code
49076
Country
Germany
Facility Name
Asklepios Fachklinikum Teupitz
City
Teupitz
ZIP/Postal Code
15755
Country
Germany
Facility Name
Neurologische Klinik, Eberhard-Karls-Universität Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Klinika Neurologii z Pododdziałem Udarowym
City
Białystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny im. Mikołaja Kopernika w Gdańsku, Oddział Neurologiczny i Leczenia Udarów Mózgu
City
Gdańsk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
II Klinika Neurologii
City
Warszawa
ZIP/Postal Code
02-957
Country
Poland
Facility Name
Instytut Psychiatrii i Neurologii, I Klinika neurologii
City
Warszawa
ZIP/Postal Code
02-957
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Łodzi, Centralny Szpital Weteranów, Klinika neurologii i epileptologii z oddziałem udarowym
City
Łódź
ZIP/Postal Code
90-549
Country
Poland
Facility Name
Comenius University Bratislava
City
Bratislava
ZIP/Postal Code
813 69
Country
Slovakia
Facility Name
4. Faculty Hospital with Policlinic
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
Facility Name
Faculty Hospital L. Derer
City
Bratislava
ZIP/Postal Code
833 05
Country
Slovakia
Facility Name
Faculty Hospital
City
Košice
ZIP/Postal Code
041 66
Country
Slovakia
Facility Name
Faculty Hospital
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
Facility Name
Faculty Hospital Nitra
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Fakultna nemocnica Trnava
City
Trnava
ZIP/Postal Code
917 75
Country
Slovakia
Facility Name
Hospital Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Dr. Josep Trueta
City
Girona
ZIP/Postal Code
17017
Country
Spain
Facility Name
Hospital de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Ramon y Cajal / Fundacion para le Investigacion Biomedica del Hospital Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hopsital Univ. La Paz / Fundacion para la Investigacion
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Univ. Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clínico Universitario
City
Valencia
ZIP/Postal Code
46010
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
33980046
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.
Results Reference
derived
PubMed Identifier
33504185
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.
Results Reference
derived
PubMed Identifier
25765724
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.
Results Reference
derived
PubMed Identifier
23963331
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.
Results Reference
derived
Learn more about this trial
AXIS 2: AX200 for the Treatment of Ischemic Stroke
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