A Double-Blind, Placebo-Controlled, Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Change From Baseline in Epworth Sleepiness Scale [ESS]
研究概览
简要总结
The objective of the study is to evaluate armodafinil as a wakefulness-promoting therapy as a means of improving residual daytime sleepiness in patients with treated nocturia.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving standard-of-care therapy for nocturia based on assessment by study physician
- •Evaluation by study physician indicates that the patient meets criteria for either overactive bladder diagnosis, or nocturnal polyuria diagnosis.
- •Mean number of nocturia episodes at least 2 per night based on day sleep/bladder diary
- •Epworth Sleepiness Scale Score of at least 10
- •Clinical Global Impression of Sleepiness at least Moderate
- •Age 18-90 years inclusive
排除标准
- •Medications affecting urinary or sleep-wake function other than therapy for OAB o or NP within 5 half-lives of baseline assessment
- •Sleep disorders other than nocturia based on history and screening assessment
- •Unstable medical or psychiatry conditions
- •Medical or psychiatric conditions affecting sleep/wake or urologic function
- •Apnea-Hypopnea Index (AHI) ≥ 15 on screening polysomnogram
- •Periodic Leg Movement Arousal Index (PLMAI) ≥ 15 on screening polysomnogram
- •History of substance abuse or dependence in the last year
- •Regular consumption of over 800 mg of caffeine use
- •Shift-work in the 3 months prior to or during the study
研究组 & 干预措施
Armodafinil First, Then Placebo
During double-blind treatment subjects took armodafinil for 4 weeks before crossing over to placebo for 4 weeks. Pill is taken once daily, before 8 am.
Armodafinil/placebo was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
干预措施: Armodafinil (Drug)
Armodafinil First, Then Placebo
During double-blind treatment subjects took armodafinil for 4 weeks before crossing over to placebo for 4 weeks. Pill is taken once daily, before 8 am.
Armodafinil/placebo was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
干预措施: Placebo (Drug)
Placebo First, Then Armodafinil
During double-blind treatment subjects took placebo for 4 weeks before crossing over to armodafinil for 4 weeks. Pill is taken once daily, before 8 am.
Armodafinil/placebo was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
干预措施: Armodafinil (Drug)
Placebo First, Then Armodafinil
During double-blind treatment subjects took placebo for 4 weeks before crossing over to armodafinil for 4 weeks. Pill is taken once daily, before 8 am.
Armodafinil/placebo was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Epworth Sleepiness Scale [ESS]
时间窗: Baseline, Week 4 of each phase
Epworth sleepiness scale (ESS) is measure of subjective sleepiness. Tendency to fall asleep in 8 situations. Total varies from zero to 24. A ESS of 10 or less is considered normal. Change is calculated as value at baseline minus value at week 4.
次要结局
- Clinical Global Impressions, Change in Severity of Excessive Daytime Sleepiness (EDS)(week 4, of each phase)
- Mean Number of Nocturic Events (Episode of Urination Preceded and Followed by Sleep)(week 4 of each phase.)
- Mean Number of Naps/Day(week 4 of each phase.)
- Mean Number of Minutes Napped Per Day Based on Sleep Diary(week 4 of each phase.)