NCT00870844

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (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) dosed once daily for 5 days 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. 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.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Lu AA24493 (CEPO)	0.5 to 50.0 mcg/kg body weight, IV, within 0 to 48 hrs from symptom onset
DRUG	Placebo	Vials with solution for IV infusion

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-12-01
• Completion: 2011-03-01
• First posted: 2009-03-27
• Last updated: 2011-04-20

Locations

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