Phase IIa, Randomized, Double-blind, Placebo-controlled, 3-period Crossover, Adaptive Dose Design, Clinical Trial to Evaluate Safety & Efficacy of MK0249 in Treating Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome Appropriately Using nCPAP Therapy.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 125
- 主要终点
- Mean of Average Maintenance of Wakefulness Test Early for The Mode Dose of MK0249 Versus Placebo
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of MK0249 in treating refractory excessive daytime sleepiness (EDS) in patients with Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) using nasal continuous positive airway pressure (nCPAP) therapy.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is male or female and is at least 18 years old and less than 65 years old
- •Patient must have a diagnosis of Obstructive Sleep Apnea/Hypopnea Syndrome
- •Patient has been using nCPAP treatment for at least 2 months prior to Visit 1
- •Patient is willing to stay at a sleep laboratory for 4 full days and nights for observation and assessments
- •Patient is willing to refrain from napping for the duration of the study
排除标准
- •Patient is pregnant, breastfeeding, or planning to become pregnant within the next 4 months
- •Patient is or has participated in a study with an investigational compound or device within 30 days of signing the informed consent
- •Patient has had asthma-related visit to the emergency room or hospitalization within 6 months of Visit 1
- •Patient has donated or received blood products within 8 weeks of signing consent or is planning on doing either for the duration of the study
结局指标
主要结局
Mean of Average Maintenance of Wakefulness Test Early for The Mode Dose of MK0249 Versus Placebo
时间窗: At Week 2
The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the mode dose of MK0249 versus placebo.
次要结局
- Clinical Global Impressions Scale of Severity Score as it Relates to Excessive Daytime Sleepiness (CGIS-EDS) for the Mode Dose of MK0249 Versus Placebo(At Week 2)
- Mean of Average Maintenance of Wakefulness Test Early for the Mode Dose of MK0249 Versus Modafinil(At Week 2)
- Mean of Average Maintenance of Wakefulness Test Early for Top 2 Doses Pooled of MK0249 Versus Modafinil(At Week 2)
- Epworth Sleepiness Scale (ESS) Score for the Mode Dose of MK0249 Versus Placebo(At Week 2)