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Completed

NCT Number: NCT00870844

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

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

FI004, Helsinki, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lu AA24493 (CEPO)

Drug

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

Placebo

Drug

Vials with solution for IV infusion

Primary outcomes

  1. National Institutes of Health Stroke Scale (NIHSS) and the modified Rankin Scale (mRS)

    Time frame: NIHSS = Baseline: Day 2, 3, 4, 5, Day 6/Discharge, Day 14, 30. mRS = Baseline, Day 6/Discharge, Day 14, 30

Secondary outcomes

  1. Pharmacokinetics, immunogenicity and biomarkers

    Time frame: Baseline, Days 1-6, Day 30

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Mar 27, 2009
Registry last updated
Apr 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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