Acute Ischemic StrokePhase 2AXIS-2NCT00927836
AXIS 2: AX200 for the Treatment of Ischemic Stroke
A Phase 2 study testing Filgrastim and Sodium chloride solution in people with Acute Ischemic Stroke, run by Sygnis Bioscience GmbH & Co KG at 58 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Filgrastim and Sodium chloride solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 328 participants
- Where
- 58 sitesin 7 countries
- Study dates
- May 2009to Nov 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
58 sites in 7 countries.
58 sites in 7 countries
Germany24 sites
Universitätsklinikum der RWTH Aachen
Aachen, 52074
Kreiskrankenhaus Altenburg gGmbH
Altenburg, 04600
Charité Universitätsmedizin Berlin
Berlin, 10117
Charite Universitätsklinikum "Benjamin Franklin" Klinik und Poliklinik für Neurologie
Berlin, 12200
Evangelisches Krankenhaus Bielefeld
Bielefeld, 33617
Klinikum Bremen-Mitte gGmbH
Bremen, 28177
Klinik für Neurologie Chemnitz
Chemnitz, 09131
Marienhospital Düsseldorf
Düsseldorf, 40479
Universität Erlangen-Nürnberg
Erlangen, 91054
Universitätsklinikum Essen
Essen, 45122
Neurologische Universitätsklinik Freiburg
Freiburg im Breisgau, 79106
Berufsgenossenschaftliche Kliniken Bergmannstrost
Halle, 06112
Universitätsklinik Hamburg Eppendorf
Hamburg, 20246
Universität Heidelberg
Heidelberg, 69120
Friedrich-Schiller-Universitätsklinikum
Jena, 07747
Universitätsklinikum Leipzig
Leipzig, 04103
Klinikum der Stadt Ludwigshafen
Ludwigshafen, 67063
Philipps-Universität Marburg
Marburg, 35039
Technische Universität München Klinikum rechts der Isar
München, 81675
Universitätsklinikum Münster
Münster, 48149
Klinikum Osnabrück GmbH
Osnabrück, 49076
Asklepios Fachklinikum Teupitz
Teupitz, 15755
Neurologische Klinik, Eberhard-Karls-Universität Tübingen
Tübingen, 72076
Universitätsklinikum Ulm
Ulm, 89081
Spain8 sites
Hospital Santa Creu i Sant Pau
Barcelona, 08025
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital Dr. Josep Trueta
Girona, 17017
Hospital de la Princesa
Madrid, 28006
Hospital Ramon y Cajal / Fundacion para le Investigacion Biomedica del Hospital Ramon y Cajal
Madrid, 28034
Hopsital Univ. La Paz / Fundacion para la Investigacion
Madrid, 28046
Hospital Univ. Virgen del Rocio
Seville, 41013
Hospital Clínico Universitario
Valencia, 46010
Czechia7 sites
St. Anne's Faculty Hospital
Brno, 656 91
Faculty Hospital
Olomouc, 775 20
Faculty Hospital Ostrava
Ostrava, 708 52
Municipal Hospital Ostrava
Ostrava, 728 80
Faculty Hospital 1
Plzeň - Lochotín, 304 60
General Faculty Hospital
Prague, 120 00
Faculty Hospital Motol
Prague, 150 06
Slovakia7 sites
Comenius University Bratislava
Bratislava, 813 69
4. Faculty Hospital with Policlinic
Bratislava, 826 06
Faculty Hospital L. Derer
Bratislava, 833 05
Faculty Hospital
Košice, 041 66
Faculty Hospital
Martin, 036 59
Faculty Hospital Nitra
Nitra, 949 01
Fakultna nemocnica Trnava
Trnava, 917 75
Poland5 sites
Klinika Neurologii z Pododdziałem Udarowym
Bialystok, 15-276
Wojewódzki Szpital Specjalistyczny im. Mikołaja Kopernika w Gdańsku, Oddział Neurologiczny i Leczenia Udarów Mózgu
Gdansk, 80-803
Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Łodzi, Centralny Szpital Weteranów, Klinika neurologii i epileptologii z oddziałem udarowym
Lodz, 90-549
II Klinika Neurologii
Warsaw, 02-957
Instytut Psychiatrii i Neurologii, I Klinika neurologii
Warsaw, 02-957
Belgium4 sites
AZ Sint-Jan AV
Bruges, 8000
Cliniques Universitaires Saint-Luc
Brussels, 1200
Universitair Ziekenhuis Gent
Ghent, 9000
UZ Gasthuisberg
Leuven, 3000
Austria3 sites
Landes-Nervenklinik Wagner-Jauregg
Linz, 4020
AHK Linz
Linz, 4021
Wilhelminenspital
Vienna, 1160
About this study
Official title: AXIS 2: AX200 for the Treatment of Ischemic Stroke - A Multinational, Multicenter, Randomized, Doubleblind, Placebo-controlled Phase II Trial
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Filgrastim, Sodium chloride solution
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilgrastimBiological
135 μg/kg body weight total dose Short term infusion (20 to 30 minutes) and continuous infusion over 3 days
Sodium chloride solutionDrug
Short term infusion (20 to 30 minutes) and continuous infusion over 3 days
| Study group | Role | What they receive |
|---|---|---|
| AX200 | Experimental | Not described Receives: Biological: Filgrastim |
| Placebo | Placebo comparator | Not described Receives: Drug: Sodium chloride solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement on mRS relative to placebo-treated patients
Measured: day 90
Secondary outcomes (1)
Improvement on NIHSS relative to placebo-treated patients
Measured: day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sygnis Bioscience GmbH & Co KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Rathgeb, Dr., Study chair, Sygnis Bioscience GmbH & Co KGRico Laage, Dr., Study director, Sygnis Bioscience GmbH & Co KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927836
- Sponsor's protocol ID
- AX200-101
- Other IDs
- EudraCT 2008-006444-19
- Acronym
- AXIS-2
- Status last verified
- Aug 2011
- First submitted
- 24 Jun 2009
- Last updated
- 13 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33980046Bu 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.
PubMed 33504185Kufner 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.
PubMed 25765724Ringelstein 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.
PubMed 23963331
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AXIS 2: AX200 for the Treatment of Ischemic Stroke - A Multinational, Multicenter, Randomized, Doubleblind, Placebo-controlled Phase II Trial
- ClinicalTrials.gov ID
- NCT00927836
- Acronym / sponsor ID
- AXIS-2 / AX200-101
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Sygnis Bioscience GmbH & Co KGIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 25 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AX200 | Experimental | Biological: Filgrastim |
| Placebo | Placebo comparator | Drug: Sodium chloride solution |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Filgrastim135 μg/kg body weight total dose Short term infusion (20 to 30 minutes) and continuous infusion over 3 days | Biological | AX200 |
| Sodium chloride solutionShort term infusion (20 to 30 minutes) and continuous infusion over 3 days | Drug | Placebo |
Primary outcome
Improvement on mRS relative to placebo-treated patients
Time frame: day 90
1 secondary outcome
Improvement on NIHSS relative to placebo-treated patients
Time frame: day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2011.
- Derived from this study: PubMed 33980046Scheldeman 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.
- Derived from this study: PubMed 33504185Bu 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.
- Derived from this study: PubMed 25765724Kufner 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.
- Derived from this study: PubMed 23963331Ringelstein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Rathgeb, Dr. study chair
Sygnis Bioscience GmbH & Co KG
Rico Laage, Dr. study director
Sygnis Bioscience GmbH & Co KG
58 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Filgrastim and Sodium chloride solution in people with Acute Ischemic Stroke, run by Sygnis Bioscience GmbH & Co KG at 58 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in Germany, Spain, Czechia, Slovakia, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement on mRS relative to placebo-treated patients (time frame: day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00927836, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2011.