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Completed

NCT Number: NCT00132470

Treatment With AX200 for Acute Ischemic Stroke

The AXIS study is a randomized, double-blind, placebo-controlled, dose-escalating phase IIa trial to investigate treatment with AX200 (granulocyte-colony stimulating factor; G-CSF) for acute ischemic stroke. The primary objective of the present phase IIa study is to assess the safety and tolerability of AX200 compared to placebo in subjects suffering from acute stroke. The secondary objective is to assess the effect of AX200 on subject outcome in comparison to placebo.

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Key information

Conditions

Cerebral Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Neurology University of Heidelberg, Heidelberg, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Stroke onset within 12 hours prior to start of study agent administration
  • Ischemic stroke in the middle cerebral artery (MCA) territory confirmed by magnetic resonance imaging (MRI)

Exclusion criteria

  • Time interval since stroke onset impossible to determine
  • Carotid T-occlusion (magnetic resonance angiography [MRA])
  • Subarachnoid hemorrhages
  • Several safety parameters

Treatment and study plan

AX200 (G-CSF)

Drug

Primary outcomes

  1. Safety

Secondary outcomes

  1. Neurological outcome

  2. ischemic lesion growth

Sponsors and collaborators

Lead sponsor

Axaron Bioscience AG

Industry

Registry information

Official study title

AXIS IIa - Treatment With AX200 for Acute Ischemic Stroke

Important dates

Study start
2004
Study completion
2007
First posted
Aug 22, 2005
Registry last updated
Jul 25, 2007

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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