NCT00174174已完成不适用
A Placebo Control, Double Blind, Cross Over Study of Modafinil in Patients With Narcolepsy
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- The change from baseline in the sleep latency.
研究概览
简要总结
The primary objective is to evaluate the therapeutic effect of excessive daytime sleepiness associated with narcolepsy. Both of the subjective and objective sleepiness of the patients were assessed in the experiment by repeat measures.
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
- Double
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Polysomnographic findings of shortened sleep latency less than 5 minutes average of Multiple Sleep Latency Test, and two or more SOREM should be fulfilled.
- •Age of 12 y/o to 55 y/o.
- •The liver and kidney functions are within normal limits.
- •Meeting the strict criteria of narcolepsy described above.
- •Wash out any medications which might enhance wakefulness or affect nocturnal sleep two weeks prior to the experiments.
- •Willingness to comply with the protocol and signed the written Informed Consent.
排除标准
- •Patients whose hypersomnia was caused by severely sleep deprived, phase delayed, or suspected long sleeper.
- •Patients with concomitant neurological disorder and psychiatric disorders.
- •Patients with sleep-related breathing disorders whose apnea/hypopnea index (AHI) was 5 pauses per hour above.
- •Patients with Restless Leg Syndrome & Periodic Limbs Movements whose index was more than 5 per hour.
- •Patients who are pregnant or breast-feeding.
结局指标
主要结局
The change from baseline in the sleep latency.
次要结局
- Patient's assessment of general level of daytime sleepiness on ESS.
- Patient's cognitive function assessed by psychomotor function test (Trail making test, and Digit Symbol Substitution Test).
- Patient's sleep quality evaluated by PSQI.
- Safety would be evaluated by tabulating and summarizing all adverse events reported.
研究者
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