Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Lu AA24493 in Acute Ischemic Stroke
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 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) 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. 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.
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 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
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 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
研究组 & 干预措施
Lu AA24493 (CEPO): 0.005 mcg/kg
干预措施: Lu AA24493 (CEPO) (Drug)
Lu AA24493 (CEPO): 0.05 mcg/kg
干预措施: Lu AA24493 (CEPO) (Drug)
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: Baseline, Day 7, Day 30; for NIHSS also Day 2 and 3
次要结局
- Pharmacokinetics, immunogenicity and mechanistic biomarkers (S-100b, glial fibrillary acidic protein (GFAP), matrix metalloproteinase 9 (MMP-9))(Baseline, Day 1-4, Day 7 and Day 30)