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

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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 |
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

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
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 |
Study Director: | Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com |
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 |
Acute ischemic stroke Erythropoietin Carbamylated Neuroprotection |
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 |