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

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Acute Ischemic Stroke

Treatments: Drug: Placebo; Drug: Lu AA24493 (CEPO)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00756249

11767A

2006-005959-15 (EudraCT Number)

Details and patient eligibility

About

The primary purpose of the study is to determine whether carbamylated erythropoietin (CEPO) is a safe treatment for patients who have suffered an acute ischemic stroke.

Full description

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.

Enrollment: 16 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

16 participants in 6 patient groups, including a placebo group

Lu AA24493 (CEPO): 0.005 mcg/kg

Experimental group

Treatment:

Drug: Lu AA24493 (CEPO)

Lu AA24493 (CEPO): 0.05 mcg/kg

Experimental group

Treatment:

Drug: Lu AA24493 (CEPO)

Lu AA24493 (CEPO): 0.5 mcg/kg

Experimental group

Treatment:

Drug: Lu AA24493 (CEPO)

Lu AA24493 (CEPO): 5.0 mcg/kg

Experimental group

Treatment:

Drug: Lu AA24493 (CEPO)

Lu AA24493 (CEPO): 50.0 mcg/kg

Experimental group

Treatment:

Drug: Lu AA24493 (CEPO)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo