Treatment With AX200 for Acute Ischemic Stroke

Cerebral Stroke Clinical Trial

Official title:

AXIS IIa - Treatment With AX200 for Acute Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132470
• Other study ID #: AX200_P2A_1
• Status: Completed
• Phase: Phase 2
• First received: August 18, 2005
• Last updated: July 23, 2007
• Start date: December 2004
• Est. completion date: March 2007

Study information

• Verified date: July 2007
• Source: Axaron Bioscience AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Stroke
• Stroke

Intervention

Drug:
• AX200 (G-CSF)

Locations

Country	Name	City	State
Germany	Neurology University of Heidelberg	Heidelberg
Germany	Neurology University of Muenster	Muenster

Sponsors (1)

Lead Sponsor	Collaborator
Axaron Bioscience AG

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Schneider A, Krüger C, Steigleder T, Weber D, Pitzer C, Laage R, Aronowski J, Maurer MH, Gassler N, Mier W, Hasselblatt M, Kollmar R, Schwab S, Sommer C, Bach A, Kuhn HG, Schäbitz WR. The hematopoietic factor G-CSF is a neuronal ligand that counteracts programmed cell death and drives neurogenesis. J Clin Invest. 2005 Aug;115(8):2083-98. Epub 2005 Jul 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety
Secondary	Neurological outcome
Secondary	ischemic lesion growth