Treatment With AX200 for Acute Ischemic Stroke

Axaron Bioscience

Status and phase: Completed; Phase 2

Conditions: Cerebral Stroke

Treatments: Drug: AX200 (G-CSF)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00132470

AX200_P2A_1

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind