Safety 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) 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. There is only one approved pharmacological treatment, Alteplase, which has to be administered within 3 hours from symptom onset. Consequently, only about 2-3% of patients world wide with ischemic strokes are treated. 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. However, treatment of stroke with EPO is undesirable due to its ability to stimulate production of red blood cells and to promote the blood to coagulate. 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.
In this safety study of single doses with Lu AA24493, patients will receive Lu AA24493 within 12-48 hours from symptom onset.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Vials with solution for IV infusion
    ARM 1: Kind: Experimental
    Label: Placebo
  • Lu AA24493 (CEPO) Drug
    Intervention Desc: 0.005 - 50.0 mcg/kg body weight, IV, within 12-48 hrs from symptom onset
    ARM 1: Kind: Experimental
    Label: Lu AA24493 (CEPO): 0.005 mcg/kg
    ARM 2: Kind: Experimental
    Label: Lu AA24493 (CEPO): 0.05 mcg/kg
    ARM 3: Kind: Experimental
    Label: Lu AA24493 (CEPO): 0.5 mcg/kg
    ARM 4: Kind: Experimental
    Label: Lu AA24493 (CEPO): 5.0 mcg/kg
    ARM 5: 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) Baseline, Day 7, Day 30; for NIHSS also Day 2 and 3 Yes
Secondary Pharmacokinetics, immunogenicity and mechanistic biomarkers (S-100b, glial fibrillary acidic protein (GFAP), matrix metalloproteinase 9 (MMP-9)) Baseline, Day 1-4, Day 7 and Day 30 No

Sponsors