Overview

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