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

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ClinicalTrials.gov Identifier: NCT00870844
Recruitment Status : Completed
First Posted : March 27, 2009
Last Update Posted : April 20, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Drug: Lu AA24493 (CEPO) Drug: Placebo Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : May 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : March 2011

Arm Intervention/treatment
Experimental: Lu AA24493 (CEPO): 0.5 mcg/kg Drug: Lu AA24493 (CEPO)
0.5 to 50.0 mcg/kg body weight, IV, within 0 to 48 hrs from symptom onset
Experimental: Lu AA24493 (CEPO): 5.0 mcg/kg Drug: Lu AA24493 (CEPO)
0.5 to 50.0 mcg/kg body weight, IV, within 0 to 48 hrs from symptom onset
Experimental: Lu AA24493 (CEPO): 50.0 mcg/kg Drug: Lu AA24493 (CEPO)
0.5 to 50.0 mcg/kg body weight, IV, within 0 to 48 hrs from symptom onset
Placebo Comparator: Placebo Drug: Placebo
Vials with solution for IV infusion



Primary Outcome Measures :
  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 Outcome Measures :
  1. Pharmacokinetics, immunogenicity and biomarkers [ Time Frame: Baseline, Days 1-6, Day 30 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00870844


Locations
Finland
FI004
Helsinki, Finland, 29
France
FR002
Paris, France, 75018
Netherlands
NL005
Breda, Netherlands, 4818 CK
Singapore
SG003
Singapore, Singapore
United Kingdom
GB001
Glasgow, United Kingdom, G11 6NT
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00870844     History of Changes
Other Study ID Numbers: 12053A
2007-003390-81 ( EudraCT Number )
First Posted: March 27, 2009    Key Record Dates
Last Update Posted: April 20, 2011
Last Verified: April 2011

Keywords provided by H. Lundbeck A/S:
Acute ischemic stroke
Erythropoietin
Carbamylated
Neuroprotection

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Epoetin Alfa
Hematinics