A Randomised, Double-blind, Placebo-controlled, Multiple-dose, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Lu AA24493 in Patients With Acute Ischemic Stroke
Overview
- Phase
- Phase 1
- Intervention
- Lu AA24493 (CEPO)
- Conditions
- Acute Ischemic Stroke
- Sponsor
- H. Lundbeck A/S
- Enrollment
- 24
- Locations
- 5
- Primary Endpoint
- National Institutes of Health Stroke Scale (NIHSS) and the modified Rankin Scale (mRS)
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief 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.
Detailed Description
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.
Investigators
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
Arms & Interventions
Lu AA24493 (CEPO): 0.5 mcg/kg
Intervention: Lu AA24493 (CEPO)
Lu AA24493 (CEPO): 5.0 mcg/kg
Intervention: Lu AA24493 (CEPO)
Lu AA24493 (CEPO): 50.0 mcg/kg
Intervention: Lu AA24493 (CEPO)
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
National Institutes of Health Stroke Scale (NIHSS) and the modified Rankin Scale (mRS)
Time Frame: NIHSS = Baseline: Day 2, 3, 4, 5, Day 6/Discharge, Day 14, 30. mRS = Baseline, Day 6/Discharge, Day 14, 30
Secondary Outcomes
- Pharmacokinetics, immunogenicity and biomarkers(Baseline, Days 1-6, Day 30)