NCT02790632终止3 期
Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study Comparing EG-1962 to Standard of Care Oral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage
Edge Therapeutics Inc79 个研究点 分布在 4 个国家目标入组 374 人开始时间: 2016年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 374
- 试验地点
- 79
- 主要终点
- Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale [Primary Efficacy Endpoint]
研究概览
简要总结
This study compares EG-1962 to enteral nimodipine 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 confirmed by angiography and repaired by neurosurgical clipping or endovascular coiling
- •External ventricular drain in place
- •Subarachnoid hemorrhage on computed tomography (CT) scan of grade 2-4 on the modified Fisher scale
- •WFNS grade 2, 3, or 4
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 a cerebral infarction with neurological deficit
研究组 & 干预措施
EG-1962 Group
Experimental
- 1 dose of intraventricular EG-1962 (nimodipine microparticles) 600 mg
- Up to 21 days of placebo capsules/tablets
干预措施: EG-1962 (nimodipine microparticles) (Drug)
Enteral Nimodipine Group
Active Comparator
- 1 dose of intraventricular normal saline
- Up to 21 days of oral nimodipine capsules/tablets
干预措施: Enteral Nimodipine (Drug)
结局指标
主要结局
Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale [Primary Efficacy Endpoint]
时间窗: 90 Days
Proportion of subjects with a favorable outcome measured on the Extended Glasgow Outcome Scale (GOSE) at Day 90
次要结局
- Proportion of subjects with favorable neurocognitive outcome measured by the Montreal Cognitive Assessment [Secondary Efficacy Endpoint](90 Days)
研究者
研究点 (79)
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