NCT01080807已完成4 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Tolerability of Armodafinil Treatment (150 mg) in Improving Clinical Condition Late in the Shift and in Improving Functional and Patient-Reported Outcomes in Adult Patients With Excessive Sleepiness Associated With Shift Work Disorder
Cephalon61 个研究点 分布在 1 个国家目标入组 385 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 385
- 试验地点
- 61
- 主要终点
- Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Endpoint
研究概览
简要总结
The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with shift work disorder (SWD) by measuring improved clinical condition late in the shift, including the commute home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient currently meets the criteria for Shift Work Disorder (SWD) for duration of at least 1 month.
- •The patient has the presence of excessive sleepiness late in the shift, including the commute home if applicable, with a Clinical Global Impression of Severity of Illness (CGI-S) rating of 4 or more at screening.
- •The patient has clinically significant difficulty in social or occupational functioning, with a Global Assessment of Function (GAF) score less than 70 (on clinician interview) at screening.
- •The patient has a Karolinska Sleepiness Scale (KSS) score of 6 or more at screening (visit 1) that is confirmed at baseline (visit 2).
- •The patient works at least 5 night shifts per month, of which at least 3 nights are consecutive, and plans to maintain this schedule.
- •The patient works night shifts or rotating shifts that include at least 6 hours between 2200 and 0800 (including the time period 0400 to 0800), and shifts are no longer than 12 hours in duration.
- •The patient is in good health, as judged by the investigator.
- •The patient is able to complete self-rating scales.
- •Women of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception, and must continue use of 1 of these methods for the duration of the study (and for 30 days after participation in the study). Acceptable methods of contraception include: abstinence, barrier method with spermicide, steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method, or intrauterine device (IUD).
- •The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol
排除标准
- •The patient has mild or more severe obstructive sleep apnea (OSA) defined as an apnea/hypopnea index more than 5 as determined by daytime polysomnography (PSG).
- •The patient has a medical or psychiatric disorder causing clinically significant functional impairment or contributing to the patient's excessive sleepiness.
- •The patient is currently taking a medication or substance that is causing clinically significant functional impairment or contributing to the patient's excessive sleepiness.
- •The patient has a clinically significant treated or untreated medical condition.
- •The patient has a history of clinically significant suicidal ideation in the judgment of the principal investigator or is currently suicidal based on medical and psychiatric history.
- •The patient has a known hypersensitivity to armodafinil, racemic modafinil, or any component of the study drug tablets.
- •The patient has a history of any clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reactions.
- •The patient consumes caffeine including coffee, tea and/or other caffeine containing beverages or food averaging more than 600 mg of caffeine per day within 7 days of the baseline visit.
- •The patient uses any prescription or over-the-counter (OTC) drugs disallowed by the protocol within 30 days of the baseline visit.
- •The patient has been in a prior armodafinil study.
- •The patient has a history of alcohol, narcotic, or any other drug abuse.
- •The patient has a positive urine drug screen (UDS) without medical explanation at the screening visit.
- •The patient has a clinically significant deviation from normal on physical examination.
- •The patient is a pregnant or lactating woman.
- •The patient has used an investigational drug within 1 month of the screening visit.
- •The patient has a disorder that could interfere with the absorption, distribution, metabolism, or excretion of the investigational product.
- •The patient needs to use any of the excluded medications in this protocol.
研究组 & 干预措施
150 mg/day armodafinil
Experimental
干预措施: Armodafinil (Drug)
Matching placebo
Placebo Comparator
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Endpoint
时间窗: Baseline and week 6 (or last observation after baseline)
The Clinical Global Impression of Change (CGI-C) is an assessment performed by the clinician, evaluating the change in the patient's symptoms over time. The clinician categorizes the change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The data presented here represents the percentage of patients whose condition showed at least minimal improvement in the CGI-C rating as related to late shift sleepiness (defined as the period 0400-0800, including the commute home).
次要结局
- Change From Baseline to Endpoint in Global Assessment of Function (GAF) Score(Baseline and week 6 (or last observation after baseline))
- Change From Baseline to Week 3 in Global Assessment of Functioning(Baseline and Week 3)
- Change From Baseline to Week 6 in Global Assessment of Functioning(Baseline and Week 6)
- Change From Baseline to Endpoint in the Mean Karolinska Sleepiness Scale (KSS) Score(Baseline and week 6 (or last observation after baseline))
- Change From Baseline to Week 3 in the Mean Karolinska Sleepiness Scale (KSS) Score(Baseline and week 3)
- Change From Baseline to Week 6 in the Mean Karolinska Sleepiness Scale (KSS) Score(Baseline and week 6)
- Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Week 3(Baseline and week 3)
- Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Week 6(Baseline and week 6)
- Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Composite Score(Baseline and week 6 (or last observation after baseline))
- Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Work Item Score(Baseline and week 6 (or last observation after baseline))
- Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Social Life Item Score(Baseline and week 6 (or last observation (or last observation after baseline)))
- Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Family Life Item Score(Baseline and week 6 (or last observation after baseline))
- Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Days Missed Work or Unable to Carry Out Responsibilities(Baseline and week 6 (or last observation after baseline))
- Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Number of Days of Reduced Productivity(Baseline and week 6 (or last observation after baseline))
- Treatment Satisfaction Questionnaire for Medication (TSQM)- Effectiveness Score at Endpoint(Endpoint)
- Treatment Satisfaction Questionnaire for Medication (TSQM)- Side Effects Score at Endpoint(Endpoint)
- Treatment Satisfaction Questionnaire for Medication (TSQM)- Convenience Score at Endpoint(Endpoint)
- Treatment Satisfaction Questionnaire for Medication (TSQM)- Global Satisfaction Score at Endpoint(Endpoint)
- Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Total Score(Baseline and week 6 (or last observation after baseline))
- Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Social Outcome(Baseline and week 6 (or last observation after baseline))
- Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Activity Level Score(Baseline and week 6 (or last observation after baseline))
- Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) General Productivity Score(Baseline and week 6 (or last observation after baseline))
- Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Vigilance Score(Baseline and week 6 (or last observation after baseline))
- Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Intimacy(Baseline and week 6 (or last observation after baseline))
研究者
研究点 (61)
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