NCT06262594招募中3 期
Lemborexant Treatment of Insomnia Linked to Epilepsy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- WASO
研究概览
简要总结
The goal of this clinical trial is to assess whether Lemborexant can improve sleep in patients with epilepsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Sleep-related focal epilepsy
- •Contraception
排除标准
- •Changes in antiseizure medication 1 month before study protocol or during study protocol
- •Concomitant medications per SUNRISE1
- •Individuals with hepatic impairment
- •Female participants who are pregnant or breastfeeding
- •Individuals with compromised respiratory function
- •Individuals with a history of complex sleep-related behaviour
- •Individuals with rare hereditary diseases of galactose intolerance such as galactosemia or glucose-galactose malabsorption
- •Individuals with a history of dependence or tolerance - abuse, dependence, rebound insomnia
- •Individuals with psychiatric disorders with abnormal thinking and behavioural changes, depression, or suicidal ideation
- •Individuals with a diagnosis of narcolepsy
研究组 & 干预措施
Placebo First
Placebo Comparator
0mg
干预措施: Lemborexant (Drug)
Placebo First
Placebo Comparator
0mg
干预措施: Placebo (Drug)
Investigational Product First
Active Comparator
10mg qhs
干预措施: Lemborexant (Drug)
Investigational Product First
Active Comparator
10mg qhs
干预措施: Placebo (Drug)
结局指标
主要结局
WASO
时间窗: 36 Days
Wake After Sleep Onset (recorded using PSG)
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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