Acute Ischemic Stroke Clinical Trial
Official title:
Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Lu AA24493 in Acute Ischemic Stroke
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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