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Completed

NCT Number: NCT00927836

AXIS 2: AX200 for the Treatment of Ischemic Stroke

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

AHK Linz, Linz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

filgrastim

Biological

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

Sodium chloride solution

Drug

Short term infusion (20 to 30 minutes) and continuous infusion over 3 days

Primary outcomes

  1. Improvement on mRS relative to placebo-treated patients

    Time frame: day 90

Secondary outcomes

  1. Improvement on NIHSS relative to placebo-treated patients

    Time frame: day 90

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Sponsors and collaborators

Lead sponsor

Sygnis Bioscience GmbH & Co KG

Industry

Registry information

Official study title

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

Acronym: AXIS-2

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 25, 2009
Registry last updated
Dec 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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