NCT02893826终止1 期
Multicenter, Controlled, Randomized, Safety and Pharmacokinetic Study Comparing Intracisternal EG-1962 to Standard of Care Enteral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage
Edge Therapeutics Inc4 个研究点 分布在 2 个国家目标入组 6 人开始时间: 2016年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Proportion of subjects with delayed cerebral infarctions present on CT at Day 30
研究概览
简要总结
Safety and Pharmacokinetic study comparing intracisternal EG-1962 to enternal nimopidine in the treatment of aneurysmal subarachnoid hemorrhage.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ruptured saccular aneurysm repaired by neurosurgical clipping
- •Subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified Fischer scale
- •WFNS grade 1 or 2 assessed during the Pre-randomization Phase. If WFNS grade 2, must not require an EVD prior to aneurysm repair
排除标准
- •Major complication during aneurysm repair such as, but not limited to, massive intraoperative hemorrhage, brain swelling, arterial occlusion or inability to secure the ruptured aneurysm
- •Angiographic vasospasm prior to randomization
- •Evidence of cerebral infarction with neurological deficit
研究组 & 干预措施
EG-1962 Group
Experimental
1 dose of intracisternal EG-1962 (nimodipine microparticles) 600 mg
干预措施: EG-1962 (nimodipine microparticles) (Drug)
Enteral Nimodipine Group
Active Comparator
Up to a total of 21 days of enteral nimodipine (including nimodipine received prior to randomization)
干预措施: Enteral Nimodipine (Drug)
结局指标
主要结局
Proportion of subjects with delayed cerebral infarctions present on CT at Day 30
时间窗: 30 Days
Incidence and severity of adverse events
时间窗: 90 Days
次要结局
- Pharmacokinetic (PK) profile of EG-1962 as measured by steady state concentration (Css)(At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and daily thereafter until hospital discharge or Day 21, whichever occurs first and Day 30)
- Pharmacokinetic (PK) profile of EG-1962 as measured by time to reach maximum drug concentration in plasma (Tmax)(At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and daily thereafter until hospital discharge or Day 21, whichever occurs first and Day 30)
- Pharmacokinetic (PK) profile of EG-1962 as measured by AUC area under the plasma concentration-time curve (AUC) from 0 to 24 hours (AUC024h)(At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours)
- Pharmacokinetic (PK) profile of EG-1962 as measured by AUC from 0 to Day 14 (AUC0-14)(At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and up to Day 14)
- Pharmacokinetic (PK) profile of EG-1962 as measured by AUC from 0 to Day 10 (AUC0-10)(At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and up to Day 10)
- Pharmacokinetic (PK) profile of EG-1962 as measured by maximum drug concentration in plasma (Cmax)(At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and daily thereafter until hospital discharge or Day 21, whichever occurs first and Day 30)
- Pharmacokinetic (PK) profile of EG-1962 as measured by AUC from 0 to last plasma concentration (AUC0-last)(At the time of the first post-operation blood draw and every 6 hours (± 30 minutes) for the first 24 hours and up to last plasma concentration)
研究者
研究点 (4)
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