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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
0.5 to 50.0 mcg/kg body weight, IV, within 0 to 48 hrs from symptom onset
Vials with solution for IV infusion
FI004
Helsinki, Finland
FR002
Paris, France
NL005
Breda, Netherlands
SG003
Singapore, Singapore
GB001
Glasgow, United Kingdom
National Institutes of Health Stroke Scale (NIHSS) and the modified Rankin Scale (mRS)
Time frame: NIHSS = Baseline: Day 2, 3, 4, 5, Day 6/Discharge, Day 14, 30. mRS = Baseline, Day 6/Discharge, Day 14, 30
Pharmacokinetics, immunogenicity and biomarkers
Time frame: Baseline, Days 1-6, Day 30
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.