Treatment With AX200 for Acute Ischemic Stroke
Phase 2
Completed
- Conditions
- Cerebral Stroke
- Registration Number
- NCT00132470
- Lead Sponsor
- Axaron Bioscience AG
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety
- Secondary Outcome Measures
Name Time Method Neurological outcome ischemic lesion growth
Trial Locations
- Locations (2)
Neurology University of Muenster
🇩🇪Muenster, Germany
Neurology University of Heidelberg
🇩🇪Heidelberg, Germany