Trial | NCT00132470  Report issue

Title

Treatment With AX200 for Acute Ischemic Stroke
AXIS IIa - Treatment With AX200 for Acute Ischemic Stroke

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    42
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.
Study Started
Dec 31
2004
Study Completion
Mar 31
2007
Last Update
Jul 25
2007
Estimate

Drug AX200 (G-CSF)

Criteria 

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
No Results Posted