NCT00594945已完成2 期
A Phase 2a, Open-label,Proof -Of-Concept Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 6
- 主要终点
- Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%).
研究概览
简要总结
Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of refractory epilepsy
- •No Nasal conditions that would preclude the use of intranasal product
排除标准
- •Subject with a clinical significant unstable medical abnormality
- •Subject currently or regularly taking Clonazepam
研究组 & 干预措施
Intranasal Clonazepam 2 mg
Experimental
干预措施: Clonazepam (Drug)
Intranasal Clonazepam 3 mg
Experimental
干预措施: Clonazepam (Drug)
Intranasal Clonazepam both Dose Groups 2 mg & 3 mg
Experimental
干预措施: Clonazepam (Drug)
结局指标
主要结局
Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%).
时间窗: Change from baseline to treatment day
Summary of video EEG number of spikes and sharp waves. Over a 24 hour period.
次要结局
未报告次要终点
研究者
研究点 (6)
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