Status:
COMPLETED
Safety and Pharmacokinetic Study of Carbamylated Erythropoietin (CEPO) to Treat Patients With Acute Ischemic Stroke
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
50-90 years
Phase:
PHASE1
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 be...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00870844
Start Date
May 1 2009
End Date
March 1 2011
Last Update
April 20 2011
Active Locations (5)
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1
FI004
Helsinki, Finland, 29
2
FR002
Paris, France, 75018
3
NL005
Breda, Netherlands, 4818 CK
4
SG003
Singapore, Singapore