A Randomized Phase 2, Double Blind, Placebo-Controlled, Multi-Center Crossover Study Of PF-03654746 As A Daily Treatment For Excessive Daytime Sleepiness (EDS) Associated With Narcolepsy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Change From Baseline in Maintenance of Wakefulness Test (MWT) Score at Day 21 of Stable Dosing Phase
研究概览
简要总结
Histaminergic agents are known to be involved with the sleep/wake cycle. This compound is a histaminergic agent which therefore may improve alertness and awakeness in patients with excessive daytime sleepiness (EDS) associated with narcolepsy. Significant improvement in EDS when treated with this compound compared to placebo in patients with narcolepsy is hypothesized.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ISDC diagnosis of narcolepsy
- •Excessive Daytime Sleepiness in association with a diagnosis of narcolepsy
- •An MWT (Maintenance of Wakefulness Test) average sleep latency of under 15 minutes at Baseline
排除标准
- •No other diagnosed sleep disorders (e.g., sleep apnea)
- •Major medical disorders
- •Major psychiatric disorders
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
PF-03654746
At the end of the second arm of the study, the patient will have completed the study and have a 7-10 day follow-up visit.
干预措施: PF-03654746 (Drug)
结局指标
主要结局
Change From Baseline in Maintenance of Wakefulness Test (MWT) Score at Day 21 of Stable Dosing Phase
时间窗: Baseline, Day 21 of stable dosing phase
MWT measured ability of participant to remain awake. Participants were instructed to try and remain awake during series of six 20-minute periods in a semi-recumbent position in dark room. Each period was terminated immediately after sleep onset or at end of 20 minutes if no sleep occurred. Poorest outcome was 0 minute the best was 20 minutes.
次要结局
- Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase(Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase)
- Change From Baseline in Brief Fatigue Inventory (BFI) Global Score at Day 5, 10, 15, 20 of Titration Phase and Day 7, 14, 21 of Stable Dosing Phase(Baseline, Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase)
- Change From Baseline in Cataplexy Episodes at Day 7, 14, 21 of Stable Dosing Phase(Baseline, Day 7, 14, 21 of stable dosing phase)
- Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Day 21 of Stable Dosing Phase(Baseline, Day 21 of stable dosing phase)
- Clinical Global Impression of Improvement (CGI-I) Scale Score(Day 5, 10, 15, 20 of titration phase; Day 7, 14, 21 of stable dosing phase)
- Computer Based Objective Cognition Testing (CogState) Groton Maze Learning Task (GMLT)(Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase)
- Computer Based Objective Cognition Testing (CogState) Detection Speed(Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase)
- Computer Based Objective Cognition Testing (CogState) Identification Speed(Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase)
- Computer Based Objective Cognition Testing (CogState) One Card Learning(Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase)
- Computer Based Objective Cognition Testing (CogState) Continuous Paired Associate Learning (CPAL)(Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase)
- Computer Based Objective Cognition Testing (CogState ) Composite Score(Baseline, Day 5, 10, 15, 20 of titration phase; Day 21 of stable dosing phase)