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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 5
- 主要终点
- National Institutes of Health Stroke Scale (NIHSS) and the modified Rankin Scale (mRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Lu AA24493 (CEPO): 0.5 mcg/kg
干预措施: Lu AA24493 (CEPO) (Drug)
Lu AA24493 (CEPO): 5.0 mcg/kg
干预措施: Lu AA24493 (CEPO) (Drug)
Lu AA24493 (CEPO): 50.0 mcg/kg
干预措施: Lu AA24493 (CEPO) (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
National Institutes of Health Stroke Scale (NIHSS) and the modified Rankin Scale (mRS)
时间窗: NIHSS = Baseline: Day 2, 3, 4, 5, Day 6/Discharge, Day 14, 30. mRS = Baseline, Day 6/Discharge, Day 14, 30
次要结局
- Pharmacokinetics, immunogenicity and biomarkers(Baseline, Days 1-6, Day 30)