NCT00046761终止2 期
A Study to Evaluate the Effects of ONO-2506 Intravenous Infusion in Patients With Acute Ischemic Stroke
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1,320
- 试验地点
- 295
- 主要终点
- Modified Rankin Scale
研究概览
简要总结
The primary objective of this study is to compare the efficacy of ONO-2506 versus placebo in neurological stroke outcome in 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
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
- •Patient must have a clinical diagnosis of acute cortical ischemic stroke.
- •Patient must be randomized into the study within six hours after the initial onset of stroke symptoms.
- •Patient must have a measurable focal neurological deficit for a minimum duration of 60 minutes.
- •Patient must have a CT or MRI examination compatible with the clinical diagnosis of acute ischemic stroke.
- •Patient must have had a pre-stroke mRS scale score of 0 or
- •Other inclusion criteria as specified in the study protocol.
排除标准
- •Patient must not have a body weight of more than 125 kg.
- •Patient must not have a CT and/or MRI with evidence of a non-ischemic mechanism, subarachnoid hemorrhage, or primary intracerebral and/or intraventricular hemorrhage.
- •Patient must not have all three of the following findings:
- •reduced level of consciousness (has score of greater than or equal to two on NIHSS Question 1a)
- •forced eye deviation or total gaze paresis (has score of 2 on NIHSS Question 2) and
- •dense hemiplegia (no movement) of upper and lower extremities (i.e., has score of 4 on NIHSS Question 5 regarding motor arm and has score of 4 on NIHSS Question 6 regarding motor leg).
- •Patient must not have neurological signs and symptoms that are rapidly improving.
- •Patient must not have a severe coexisting or terminal systemic disease.
- •Patient must not be pregnant or lactating.
- •Patient must not have impaired hepatic function; bilirubin greater than 2 mg/dL and or ascites.
- •Patient must not have impaired renal function; serum creatinine greater than 2 mg/dL.
- •Patient must not have congestive heart failure.
- •Patient must not have a baseline ECG showing a PR interval greater than 200 milliseconds, or a corrected QT interval of greater than 480 milliseconds, or a history of ventricular arrhythmias, or a Mobitz Type 1 or greater AV block.
- •Patient must not have other exclusion criteria as specified in the study protocol.
结局指标
主要结局
Modified Rankin Scale
次要结局
未报告次要终点
研究者
研究点 (295)
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