NCT00756249

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

Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Lu AA24493 in Acute Ischemic Stroke

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Lu AA24493 (CEPO)	0.005 - 50.0 mcg/kg body weight, IV, within 12-48 hrs from symptom onset
DRUG	Placebo	Vials with solution for IV infusion

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-09-01
• Completion: 2008-12-01
• First posted: 2008-09-22
• Last updated: 2010-09-27

Locations

5 sites across 5 countries: Finland, France, Netherlands, Singapore, United Kingdom