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

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ClinicalTrials.gov Identifier: NCT00756249
Recruitment Status : Completed
First Posted : September 22, 2008
Last Update Posted : September 27, 2010
Sponsor:
Information provided by:
H. Lundbeck A/S

Study Description
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Brief Summary:
The primary purpose of the study is to determine whether carbamylated erythropoietin (CEPO) 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. There is only one approved pharmacological treatment, Alteplase, which has to be administered within 3 hours from symptom onset. Consequently, only about 2-3% of patients world wide with ischemic strokes are treated. 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. However, treatment of stroke with EPO is undesirable due to its ability to stimulate production of red blood cells and to promote the blood to coagulate. 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.

In this safety study of single doses with Lu AA24493, patients will receive Lu AA24493 within 12-48 hours from symptom onset.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Lu AA24493 in Acute Ischemic Stroke
Study Start Date : October 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : December 2008
Arms and Interventions
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Arm Intervention/treatment
Experimental: Lu AA24493 (CEPO): 0.005 mcg/kg Drug: Lu AA24493 (CEPO)
0.005 - 50.0 mcg/kg body weight, IV, within 12-48 hrs from symptom onset
Experimental: Lu AA24493 (CEPO): 0.05 mcg/kg Drug: Lu AA24493 (CEPO)
0.005 - 50.0 mcg/kg body weight, IV, within 12-48 hrs from symptom onset
Experimental: Lu AA24493 (CEPO): 0.5 mcg/kg Drug: Lu AA24493 (CEPO)
0.005 - 50.0 mcg/kg body weight, IV, within 12-48 hrs from symptom onset
Experimental: Lu AA24493 (CEPO): 5.0 mcg/kg Drug: Lu AA24493 (CEPO)
0.005 - 50.0 mcg/kg body weight, IV, within 12-48 hrs from symptom onset
Experimental: Lu AA24493 (CEPO): 50.0 mcg/kg Drug: Lu AA24493 (CEPO)
0.005 - 50.0 mcg/kg body weight, IV, within 12-48 hrs from symptom onset
Placebo Comparator: Placebo Drug: Placebo
Vials with solution for IV infusion


Outcome Measures
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Primary Outcome Measures :
  1. National Institutes of Health Stroke Scale (NIHSS) and the modified Rankin Scale (mRS) [ Time Frame: Baseline, Day 7, Day 30; for NIHSS also Day 2 and 3 ]

Secondary Outcome Measures :
  1. Pharmacokinetics, immunogenicity and mechanistic biomarkers (S-100b, glial fibrillary acidic protein (GFAP), matrix metalloproteinase 9 (MMP-9)) [ Time Frame: Baseline, Day 1-4, Day 7 and Day 30 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
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 12 hours and 48 hours after the onset of stroke
  • Expected hospital stay of at least 72 hours after 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 excluded ICH then eligible)
  • Score >0 on the NIHSS item 1a
  • Pre-stroke mRS score >1
  • Uncontrolled hypertension
  • Previous treatment with erythropoietin
  • Clinically significant abnormal ECG
  • Cerebral pathology
  • Received or donated blood within previous 3 months
Contacts and Locations
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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): NCT00756249


Locations
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Finland
FI004
Helsinki, Finland, 00029 HUS
France
FR002
Paris, France, 75018
Netherlands
NL005
Breda, Netherlands, 4818 CK
Singapore
SG003
Singapore, Singapore, 119074
United Kingdom
GB001
Glasgow, United Kingdom, G11 6NT
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
More Information
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00756249    
Other Study ID Numbers: 11767A
2006-005959-15 ( EudraCT Number )
First Posted: September 22, 2008    Key Record Dates
Last Update Posted: September 27, 2010
Last Verified: September 2010
Keywords provided by H. Lundbeck A/S:
Acute ischemic stroke
Erythropoietin
Carbamylated
Neuroprotection
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia