Safety and Pharmacokinetic Study of Carbamylated Erythropoietin (CEPO) to Treat Patients With Acute Ischemic Stroke

Completed

Phase 1 Results N/A

Trial Description

The primary purpose of the study is to determine whether carbamylated erythropoietin (CEPO) dosed once daily for 5 days is a safe treatment for patients who have suffered an acute ischemic stroke.

Detailed Description

Acute ischemic stroke is a major cause of death and severe disability. The naturally occurring hormone, erythropoietin (EPO), is able to protect various neuronal tissues from ischemic injury and is beneficial in animal models of acute ischemic stroke. Lu AA24493 is a modified (carbamylated) version of EPO, neuroprotective but without the haematopoietic side effects. Lu AA24493 is developed for treatment of patients with acute ischemic stroke.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Vials with solution for IV infusion
    ARM 1: Kind: Experimental
    Label: Placebo
  • Lu AA24493 (CEPO) Drug
    Intervention Desc: 0.5 to 50.0 mcg/kg body weight, IV, within 0 to 48 hrs from symptom onset
    ARM 1: Kind: Experimental
    Label: Lu AA24493 (CEPO): 0.5 mcg/kg
    ARM 2: Kind: Experimental
    Label: Lu AA24493 (CEPO): 5.0 mcg/kg
    ARM 3: Kind: Experimental
    Label: Lu AA24493 (CEPO): 50.0 mcg/kg

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary National Institutes of Health Stroke Scale (NIHSS) and the modified Rankin Scale (mRS) NIHSS = Baseline: Day 2, 3, 4, 5, Day 6/Discharge, Day 14, 30. mRS = Baseline, Day 6/Discharge, Day 14, 30 Yes
Secondary Pharmacokinetics, immunogenicity and biomarkers Baseline, Days 1-6, Day 30 No

Sponsors