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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00870844

Enrollment

Registered

2009-03-27

Start date

2009-05-31

Completion date

2011-03-31

Last updated

2011-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Keywords

Acute ischemic stroke, Erythropoietin, Carbamylated, Neuroprotection

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.

Interventions

DRUGLu AA24493 (CEPO)

0.5 to 50.0 mcg/kg body weight, IV, within 0 to 48 hrs from symptom onset

DRUGPlacebo

Vials with solution for IV infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Pharmacokinetics, immunogenicity and biomarkers	Baseline, Days 1-6, Day 30

Countries

Finland, France, Netherlands, Singapore, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026