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

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S
• Treatments: Epoetin Alfa

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 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 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 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