Treatment With AX200 for Acute Ischemic Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2007-03-31

Brief Summary

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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

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Conditions

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Cerebral Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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AX200 (G-CSF)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Wolf-Rüdiger Schäbitz, MD

Role: PRINCIPAL_INVESTIGATOR

Universität Münster

Locations

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Neurology University of Heidelberg

Heidelberg, , Germany

Site Status

Neurology University of Muenster

Münster, , Germany

Site Status

Countries

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Germany

References

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Schneider A, Kruger 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, Schabitz 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. doi: 10.1172/JCI23559. Epub 2005 Jul 7.

Reference Type BACKGROUND

PMID: 16007267 (View on PubMed)

Schabitz WR, Laage R, Vogt G, Koch W, Kollmar R, Schwab S, Schneider D, Hamann GF, Rosenkranz M, Veltkamp R, Fiebach JB, Hacke W, Grotta JC, Fisher M, Schneider A. AXIS: a trial of intravenous granulocyte colony-stimulating factor in acute ischemic stroke. Stroke. 2010 Nov;41(11):2545-51. doi: 10.1161/STROKEAHA.110.579508. Epub 2010 Oct 14.

Reference Type DERIVED

PMID: 20947859 (View on PubMed)

Other Identifiers

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AX200_P2A_1

Identifier Type: -

Identifier Source: org_study_id