AXIS 2: AX200 for the Treatment of Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

— AXIS-2  

Official title:

AXIS 2: AX200 for the Treatment of Ischemic Stroke - A Multinational, Multicenter, Randomized, Doubleblind, Placebo-controlled Phase II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927836
• Other study ID #: AX200-101
• Secondary ID: EudraCT 2008-006
• Status: Completed
• Phase: Phase 2
• First received: June 24, 2009
• Last updated: December 12, 2011
• Start date: May 2009
• Est. completion date: November 2011

Study information

• Verified date: August 2011
• Source: Sygnis Bioscience GmbH & Co KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health CareBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentCzech Republic: State Institute for Drug ControlGermany: Federal Institute for Drugs and Medical DevicesPoland: Ministry of HealthSlovakia: State Institute for Drug ControlSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemia
• Stroke

Intervention

Biological:
• Filgrastim
135 µg/kg body weight total dose Short term infusion (20 to 30 minutes) and continuous infusion over 3 days

Drug:
• Sodium chloride solution
Short term infusion (20 to 30 minutes) and continuous infusion over 3 days

Locations

Country	Name	City	State
Austria	AHK Linz	Linz
Austria	Landes-Nervenklinik Wagner-Jauregg	Linz
Austria	Wilhelminenspital	Wien
Belgium	AZ Sint-Jan AV	Brugge
Belgium	Cliniques Universitaires Saint-Luc	Bruxelles
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	UZ Gasthuisberg	Leuven
Czech Republic	St. Anne's Faculty Hospital	Brno
Czech Republic	Faculty Hospital	Olomouc
Czech Republic	Faculty Hospital Ostrava	Ostrava
Czech Republic	Municipal Hospital Ostrava	Ostrava
Czech Republic	Faculty Hospital 1	Plzen - Lochotín
Czech Republic	Faculty Hospital Motol	Praha
Czech Republic	General Faculty Hospital	Praha
Germany	Universitätsklinikum der RWTH Aachen	Aachen
Germany	Kreiskrankenhaus Altenburg gGmbH	Altenburg
Germany	Charite Universitätsklinikum "Benjamin Franklin" Klinik und Poliklinik für Neurologie	Berlin
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	Evangelisches Krankenhaus Bielefeld	Bielefeld
Germany	Klinikum Bremen-Mitte gGmbH	Bremen
Germany	Klinik für Neurologie Chemnitz	Chemnitz
Germany	Marienhospital Düsseldorf	Düsseldorf
Germany	Universität Erlangen-Nürnberg	Erlangen
Germany	Universitätsklinikum Essen	Essen
Germany	Neurologische Universitätsklinik Freiburg	Freiburg
Germany	Berufsgenossenschaftliche Kliniken Bergmannstrost	Halle (Saale)
Germany	Universitätsklinik Hamburg Eppendorf	Hamburg
Germany	Universität Heidelberg	Heidelberg
Germany	Friedrich-Schiller-Universitätsklinikum	Jena
Germany	Universitätsklinikum Leipzig	Leipzig
Germany	Klinikum der Stadt Ludwigshafen	Ludwigshafen
Germany	Philipps-Universität Marburg	Marburg
Germany	Technische Universität München Klinikum rechts der Isar	München
Germany	Universitätsklinikum Münster	Münster
Germany	Klinikum Osnabrück GmbH	Osnabrück
Germany	Asklepios Fachklinikum Teupitz	Teupitz
Germany	Neurologische Klinik, Eberhard-Karls-Universität Tübingen	Tübingen
Germany	Universitätsklinikum Ulm	Ulm
Poland	Klinika Neurologii z Pododdzialem Udarowym	Bialystok
Poland	Wojewódzki Szpital Specjalistyczny im. Mikolaja Kopernika w Gdansku, Oddzial Neurologiczny i Leczenia Udarów Mózgu	Gdansk
Poland	Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Lodzi, Centralny Szpital Weteranów, Klinika neurologii i epileptologii z oddzialem udarowym	Lódz
Poland	II Klinika Neurologii	Warszawa
Poland	Instytut Psychiatrii i Neurologii, I Klinika neurologii	Warszawa
Slovakia	4. Faculty Hospital with Policlinic	Bratislava
Slovakia	Comenius University Bratislava	Bratislava
Slovakia	Faculty Hospital L. Derer	Bratislava
Slovakia	Faculty Hospital	Košice
Slovakia	Faculty Hospital	Martin
Slovakia	Faculty Hospital Nitra	Nitra
Slovakia	Fakultna nemocnica Trnava	Trnava
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital Santa Creu i Sant Pau	Barcelona
Spain	Hospital Dr. Josep Trueta	Girona
Spain	Hopsital Univ. La Paz / Fundacion para la Investigacion	Madrid
Spain	Hospital de la Princesa	Madrid
Spain	Hospital Ramon y Cajal / Fundacion para le Investigacion Biomedica del Hospital Ramon y Cajal	Madrid
Spain	Hospital Univ. Virgen del Rocio	Sevilla
Spain	Hospital Clínico Universitario	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Sygnis Bioscience GmbH & Co KG

Countries where clinical trial is conducted

Austria,  Belgium,  Czech Republic,  Germany,  Poland,  Slovakia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement on mRS relative to placebo-treated patients		day 90	No
Secondary	Improvement on NIHSS relative to placebo-treated patients		day 90	No