AXIS 2: AX200 for the Treatment of Ischemic Stroke (AXIS-2)

December 12, 2011 updated by: Sygnis Bioscience GmbH & Co KG

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

328

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, 4020
        • Landes-Nervenklinik Wagner-Jauregg
      • Linz, Austria, 4021
        • AHK Linz
      • Wien, Austria, 1160
        • Wilhelminenspital
  • Belgium
      • Brugge, Belgium, 8000
        • AZ Sint-Jan AV
      • Bruxelles, Belgium, 1200
        • Cliniques universitaires Saint-Luc
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium, 3000
        • UZ Gasthuisberg
  • Czech Republic
      • Brno, Czech Republic, 656 91
        • St. Anne's Faculty Hospital
      • Olomouc, Czech Republic, 775 20
        • Faculty Hospital
      • Ostrava, Czech Republic, 708 52
        • Faculty Hospital Ostrava
      • Ostrava, Czech Republic, 728 80
        • Municipal Hospital Ostrava
      • Plzeň - Lochotín, Czech Republic, 304 60
        • Faculty Hospital 1
      • Praha, Czech Republic, 120 00
        • General Faculty Hospital
      • Praha, Czech Republic, 150 06
        • Faculty Hospital Motol
  • Germany
      • Aachen, Germany, 52074
        • Universitätsklinikum der RWTH Aachen
      • Altenburg, Germany, 04600
        • Kreiskrankenhaus Altenburg gGmbH
      • Berlin, Germany, 10117
        • Charité Universitätsmedizin Berlin
      • Berlin, Germany, 12200
        • Charite Universitätsklinikum "Benjamin Franklin" Klinik und Poliklinik für Neurologie
      • Bielefeld, Germany, 33617
        • Evangelisches Krankenhaus Bielefeld
      • Bremen, Germany, 28177
        • Klinikum Bremen-Mitte gGmbH
      • Chemnitz, Germany, 09131
        • Klinik für Neurologie Chemnitz
      • Düsseldorf, Germany, 40479
        • Marienhospital Düsseldorf
      • Erlangen, Germany, 91054
        • Universität Erlangen-Nurnberg
      • Essen, Germany, 45122
        • Universitätsklinikum Essen
      • Freiburg, Germany, 79106
        • Neurologische Universitätsklinik Freiburg
      • Halle (Saale), Germany, 06112
        • Berufsgenossenschaftliche Kliniken Bergmannstrost
      • Hamburg, Germany, 20246
        • Universitätsklinik Hamburg Eppendorf
      • Heidelberg, Germany, 69120
        • Universitat Heidelberg
      • Jena, Germany, 07747
        • Friedrich-Schiller-Universitätsklinikum
      • Leipzig, Germany, 04103
        • Universitatsklinikum Leipzig
      • Ludwigshafen, Germany, 67063
        • Klinikum der Stadt Ludwigshafen
      • Marburg, Germany, 35039
        • Philipps-Universität Marburg
      • München, Germany, 81675
        • Technische Universität München Klinikum rechts der Isar
      • Münster, Germany, 48149
        • Universitätsklinikum Münster
      • Osnabrück, Germany, 49076
        • Klinikum Osnabrück GmbH
      • Teupitz, Germany, 15755
        • ASKLEPIOS Fachklinikum Teupitz
      • Tübingen, Germany, 72076
        • Neurologische Klinik, Eberhard-Karls-Universität Tübingen
      • Ulm, Germany, 89081
        • Universitätsklinikum Ulm
  • Poland
      • Białystok, Poland, 15-276
        • Klinika Neurologii z Pododdziałem Udarowym
      • Gdańsk, Poland, 80-803
        • Wojewódzki Szpital Specjalistyczny im. Mikołaja Kopernika w Gdańsku, Oddział Neurologiczny i Leczenia Udarów Mózgu
      • Warszawa, Poland, 02-957
        • II Klinika Neurologii
      • Warszawa, Poland, 02-957
        • Instytut Psychiatrii i Neurologii, I Klinika neurologii
      • Łódź, Poland, 90-549
        • Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Łodzi, Centralny Szpital Weteranów, Klinika neurologii i epileptologii z oddziałem udarowym
  • Slovakia
      • Bratislava, Slovakia, 813 69
        • Comenius University Bratislava
      • Bratislava, Slovakia, 826 06
        • 4. Faculty Hospital with Policlinic
      • Bratislava, Slovakia, 833 05
        • Faculty Hospital L. Derer
      • Košice, Slovakia, 041 66
        • Faculty Hospital
      • Martin, Slovakia, 036 59
        • Faculty Hospital
      • Nitra, Slovakia, 949 01
        • Faculty Hospital Nitra
      • Trnava, Slovakia, 917 75
        • Fakultna nemocnica Trnava
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic De Barcelona
      • Barcelona, Spain, 08025
        • Hospital Santa Creu i Sant Pau
      • Girona, Spain, 17017
        • Hospital Dr. Josep Trueta
      • Madrid, Spain, 28006
        • Hospital De La Princesa
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal / Fundacion para le Investigacion Biomedica del Hospital Ramon y Cajal
      • Madrid, Spain, 28046
        • Hopsital Univ. La Paz / Fundacion para la Investigacion
      • Sevilla, Spain, 41013
        • Hospital Univ. Virgen del Rocío
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Sodium chloride solution
Short term infusion (20 to 30 minutes) and continuous infusion over 3 days
EXPERIMENTAL: AX200
Biological: Filgrastim
135 μg/kg body weight total dose Short term infusion (20 to 30 minutes) and continuous infusion over 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement on mRS relative to placebo-treated patients
Time Frame: day 90
day 90

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement on NIHSS relative to placebo-treated patients
Time Frame: day 90
day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sygnis Bioscience GmbH & Co KG

Investigators

  • Study Chair: Frank Rathgeb, Dr., Sygnis Bioscience GmbH & Co KG
  • Study Director: Rico Laage, Dr., Sygnis Bioscience GmbH & Co KG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

November 1, 2011

Study Registration Dates

First Submitted

June 24, 2009

First Submitted That Met QC Criteria

June 24, 2009

First Posted (ESTIMATE)

June 25, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 13, 2011

Last Update Submitted That Met QC Criteria

December 12, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AX200-101
  • EudraCT 2008-006444-19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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