Status:
COMPLETED
Safety 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) 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. There is only one approved pharmacological treatment, Alteplase, which has to be administered within 3 hours from symptom onset. ...
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 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
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00756249
Start Date
October 1 2007
End Date
December 1 2008
Last Update
September 27 2010
Active Locations (5)
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1
FI004
Helsinki, Finland, 00029 HUS
2
FR002
Paris, France, 75018
3
NL005
Breda, Netherlands, 4818 CK
4
SG003
Singapore, Singapore, 119074