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

Completed

Phase 1 Results N/A

Eligibility 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