AXIS 2: AX200 for the Treatment of Ischemic Stroke "AXIS-2"

Completed

Phase 2 Results N/A

Trial Description

The purpose of this study is to assess the efficacy of AX200 (filgrastim) in the treatment of acute ischemic stroke and to assess the safety and tolerability of AX200.

Conditions

Interventions

  • Filgrastim Drug
    Other Names: Leukostim
    Intervention Desc: 135 μg/kg body weight total dose Short term infusion (20 to 30 minutes) and continuous infusion over 3 days
    ARM 1: Kind: Experimental
    Label: AX200
  • Sodium chloride solution Drug
    Intervention Desc: Short term infusion (20 to 30 minutes) and continuous infusion over 3 days
    ARM 1: Kind: Experimental
    Label: Placebo

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Improvement on mRS relative to placebo-treated patients day 90 No
Secondary Improvement on NIHSS relative to placebo-treated patients day 90 No

Sponsors