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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-003390-81 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AA24493 (CEPO): 0.5 mcg/kg | Experimental |
| |
| Lu AA24493 (CEPO): 5.0 mcg/kg | Experimental |
| |
| Lu AA24493 (CEPO): 50.0 mcg/kg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AA24493 (CEPO) | Drug | 0.5 to 50.0 mcg/kg body weight, IV, within 0 to 48 hrs from symptom onset |
|
| Measure | Description | Time Frame |
|---|---|---|
| National Institutes of Health Stroke Scale (NIHSS) and the modified Rankin Scale (mRS) | NIHSS = Baseline: Day 2, 3, 4, 5, Day 6/Discharge, Day 14, 30. mRS = Baseline, Day 6/Discharge, Day 14, 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics, immunogenicity and biomarkers | Baseline, Days 1-6, Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FI004 | Helsinki | 29 | Finland | |||
| FR002 |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Placebo | Drug | Vials with solution for IV infusion |
|
| Paris |
| 75018 |
| France |
| NL005 | Breda | 4818 CK | Netherlands |
| SG003 | Singapore | Singapore |
| GB001 | Glasgow | G11 6NT | United Kingdom |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |