Treatment With AX200 for Acute Ischemic Stroke

AXIS IIa - Treatment With AX200 for Acute Ischemic Stroke

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00132470

Enrollment

Registered

2005-08-22

Start date

2004-12-31

Completion date

2007-03-31

Last updated

2007-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Stroke

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.

Interventions

DRUGAX200 (G-CSF)

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety	—

Secondary

Measure	Time frame
Neurological outcome	—
ischemic lesion growth	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026