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

Phase 1

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: Lu AA24493 (CEPO); Drug: Placebo

• Registration Number: NCT00870844
• Lead Sponsor: H. Lundbeck A/S

Brief 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.

Study Timeline

• Study First Submitted: 2009-03-26
• Study First Submitted QC: 2009-03-26
• Study First Posted: 2009-03-27
• Study Start: 2009-05
• Primary Completion: 2010-12
• Study Completion: 2011-03
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-19
• Last Update Posted: 2011-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Age between 50 and 90 years
• Clinical diagnosis of acute ischemic stroke
• Measurable stroke-related deficit
• Patient is stable
• Treatment can be initiated between 0 hours and 48 hours after the onset of stroke
• Expected hospital stay of at least 120 hours after first dose of study medication
• If female then not of childbearing potential

Exclusion Criteria

• Primary intracerebral haemorrhage (ICH), or parenchymal haemorrhagic transformation of infarction (type PHI or PHII as defined in ECASS), subarachnoid haemorrhage (SAH), arterio-venous malformation (AVM), cerebral aneurysm, or cerebral neoplasm
• Treated with a thrombolytic <24 hours (if >24 hours and excluded ICH then eligible)
• Score >=1 on the NIHSS item 1a
• Pre-stroke mRS score >=2
• Uncontrolled hypertension
• Previous treatment with erythropoietin
• Previous exposure to Lu AA24493

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lu AA24493 (CEPO): 0.5 mcg/kg	Lu AA24493 (CEPO)	-
Lu AA24493 (CEPO): 5.0 mcg/kg	Lu AA24493 (CEPO)	-
Lu AA24493 (CEPO): 50.0 mcg/kg	Lu AA24493 (CEPO)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics, immunogenicity and biomarkers	Baseline, Days 1-6, Day 30

Trial Locations

Locations (5)

SG003; 🇸🇬 Singapore, Singapore

FI004; 🇫🇮 Helsinki, Finland

NL005; 🇳🇱 Breda, Netherlands

FR002; 🇫🇷 Paris, France

GB001; 🇬🇧 Glasgow, United Kingdom