Treatment With AX200 for Acute Ischemic Stroke

Completed

Phase 2 Results

Trial Description

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.

Conditions

Interventions

  • AX-200 (G-CSF)Drug
    Intervention Desc: Granulocyte Colony-Stimulating Factor (G-CSF or GCSF) is a colony-stimulating factor hormone. It is a glycoprotein, growth factor or cytokine produced by a number of different tissues to stimulate the bone marrow to produce granulocytes and stem cells.
  • AX200 (G-CSF) Drug

Trial Design

  • Allocation: Randomized
  • Masking: Double-Blind
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Patient Involvement

Eligible patients will be randomized on a 1:2 basis to receive either placebo or one of four doses of Ax 200. AX 200 will be administered in 4 different escalating doses (30, 90, 135, 180 µg/kg total) as i.v. infusion.

Outcomes

Type Measure Time Frame Safety Issue
Secondary Neurological outcome; ischemic lesion growth.
Primary Safety
Secondary Neurological outcome
Secondary ischemic lesion growth

Sponsors