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.
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.
- 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
- Allocation: Randomized
- Masking: Double Blind (Subject, Investigator)
- Purpose: Treatment
- Endpoint: Safety Study
- Intervention: Parallel Assignment
|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|
- H. Lundbeck A/S Lead