A Phase II, Multi-centre, Two-part Study to Evaluate the Safety and Efficacy of Study Drug in Acute Ischaemic Stroke.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 28
- 主要终点
- To establish the safety of five dose levels (1.0, 2.5, 5, 7.5 and 10 mg/kg)of V10153 in patients with acute ischaemic stroke.
研究概览
简要总结
A Phase II study to evaluate the safety and efficacy of five dose levels of study drug in acute ischaemic stroke
详细描述
An open label, dose escalation study where patients with acute ischaemic stroke will receive a single intravenous dose of study drug. There will be five dose levels with groups of 10 patients in each. Escalation to higher doses will occur following review of safety data from the previous dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Onset of new neurological signs of stroke within 3 to 9 hours of the time to initiation of treatment
- •Aged 18 and above
- •Provide consent
- •Cerebral CT scan to show findings of early ischaemic changes consistent with the clinical diagnosis and an ASPECT score of between 5 and 10 inclusive.
- •NIHSS score greater than 5 or less than or equal to
排除标准
- •Stroke with unknown time of onset
- •Minor stroke symptoms and sings (<6 points on the NIHSS) which are rapidly improving by the time of randomisation.
- •Major stroke symptoms and signs (>20 on the NIHSS)
- •History of stroke in previous 6 weeks
- •History of brain tumours
- •CT scan results in an ASPECT score of <5
- •Haemorrhagic risk
- •Abnormal laboratory values
- •Positive urine pregnancy test, lactation or parturition within previous 30 days.
- •Weight >135 kg
- •Uncontrolled hypertension.
- •Raised blood glucose
- •History of or current serious illness
- •Participation in another clinical trial within 4 weeks of drug administration
研究组 & 干预措施
V10153, 1.0 mg/kg
Single acute intravenous bolus dose
干预措施: V10153 (Drug)
V10153, 2.5 mg/kg
Single acute intravenous bolus dose
干预措施: V10153 (Drug)
V10153, 5.0 mg/kg
Single acute intravenous bolus dose
干预措施: V10153 (Drug)
V10153, 7.5 mg/kg
Single acute intravenous bolus dose
干预措施: V10153 (Drug)
V10153, 10 mg/kg
Single acute intravenous bolus dose
干预措施: V10153 (Drug)
结局指标
主要结局
To establish the safety of five dose levels (1.0, 2.5, 5, 7.5 and 10 mg/kg)of V10153 in patients with acute ischaemic stroke.
时间窗: Ongoing
次要结局
- To compare recanalisation rates across dose levels.(Ongoing)
- To compare clinical outcome between treatments by NIHSS, Modified Rankin Scale and Barthel Index.(Post-study completion)