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

• ClinicalTrials.gov Identifier: NCT00927836
• Recruitment Status: Completed
• First Posted: June 25, 2009
• Last Update Posted: December 13, 2011
• Sponsor: Sygnis Bioscience GmbH & Co KG
• Information provided by (Responsible Party): Sygnis Bioscience GmbH & Co KG

Tracking Information

• First Submitted Date: June 24, 2009
• First Posted Date: June 25, 2009
• Last Update Posted Date: December 13, 2011
• Study Start Date: May 2009
• Actual Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 24, 2009): Improvement on mRS relative to placebo-treated patients [ Time Frame: day 90 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: June 24, 2009): Improvement on NIHSS relative to placebo-treated patients [ Time Frame: day 90 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Acute Ischemic 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

Study Arms

• Experimental: AX200
  Intervention: Biological: Filgrastim
• Placebo Comparator: Placebo
  Intervention: Drug: Sodium chloride solution

Publications *

• 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.
• Kufner A, Wouters A, Bracoud L, Laage R, Schneider A, Schäbitz 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.
• Ringelstein EB, Thijs V, Norrving B, Chamorro A, Aichner F, Grond M, Saver J, Laage R, Schneider A, Rathgeb F, Vogt G, Charissé G, Fiebach JB, Schwab S, Schäbitz WR, Kollmar R, Fisher M, Brozman M, Skoloudik D, Gruber F, Serena Leal J, Veltkamp R, Köhrmann 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 10, 2010): 328
• Original Estimated Enrollment (submitted: June 24, 2009): 350
• Actual Study Completion Date: November 2011
• Actual Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Belgium, Czech Republic, Germany, Poland, Slovakia, Spain
• Removed Location Countries: Sweden

Administrative Information

• NCT Number: NCT00927836
• Other Study ID Numbers: AX200-101; EudraCT 2008-006444-19
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Sygnis Bioscience GmbH & Co KG
• Study Sponsor: Sygnis Bioscience GmbH & Co KG
• Collaborators: Not Provided

Investigators

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

• PRS Account: Sygnis Bioscience GmbH & Co KG
• Verification Date: August 2011