A 12 Week, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CEP 10953 (150 and 250 mg/Day) as Treatment for Adults With Residual Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 395
- 主要终点
- Maintenance of Wakefulness Test (MWT)
研究概览
简要总结
The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (30-minute version) (average of 4 naps at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI-C) ratings (as related to general condition) at week 12, or last post-baseline visit.
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
- Double
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
- •Patients are included in the study if all of the following criteria are met:
- •Written informed consent is obtained.
- •The patient is an outpatient, man or woman of any ethnic origin, 18 to 65 years of age (inclusive).
- •The patient has a complaint of excessive sleepiness despite nCPAP therapy being effective and being a regular user of nCPAP therapy.
- •The patient has a current diagnosis of OSAHS according to International Classification of Sleep Disorders (ICSD) criteria.
- •The patient meets the following nCPAP therapy requirements:
- •Adequate education and intervention efforts to encourage nCPAP therapy use must be documented.
- •A patient's nCPAP therapy regimen must be stable for at least 4 weeks.
- •nCPAP therapy is shown to be effective, with effectiveness defined as having an apnea-hypopnea index (AHI) of 10 or less during nocturnal PSG, and, in the opinion of the investigator, nCPAP is effective therapy.
- •Following demonstration of effectiveness, evidence of regular nCPAP usage must be shown during a 2-week evaluation period (ie, nCPAP usage for at least 4 hours/night on at least 70% of the nights).
- •The patient is in good health as determined by a medical and psychiatric history, physical examination, ECG, and serum chemistry and hematology.
- •Women must be surgically sterile, 2 years postmenopausal, or, if of child-bearing potential, using a medically accepted method of birth control (ie, barrier method with spermicide, steroidal contraceptive [oral, implanted, and Depo-Provera contraceptives must be used in conjunction with a barrier method], or intrauterine device [IUD]) and agree to continued use of this method for the duration of the study.
- •The patient has a Clinical Global Impression of Severity of Illness (CGI-S) rating of 4 or more.
- •The patient has an ESS score of 10 or more.
- •The patient does not have any medical or psychiatric disorders that could account for the excessive sleepiness.
- •The patient is able to complete self rating scales and computer-based testing.
- •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
- •Patients are excluded from participating in this study if 1 or more of the following criteria are met:
- •has any clinically significant, uncontrolled medical or psychiatric conditions (treated or untreated)
- •has a probable diagnosis of a current sleep disorder other than OSAHS
- •consumes caffeine including coffee, tea and/or other caffeine containing beverages or food averaging more than 600 mg of caffeine per day
- •used any prescription drugs disallowed by the protocol or clinically significant use of over the-counter (OTC) drugs within 7 days before the second screening visit
- •has a history of alcohol, narcotic, or any other drug abuse as defined by the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, 4th Edition (DSM IV)
- •has a positive urine drug screen (UDS)
- •has a clinically significant deviation from normal in the physical examination
- •is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
- •has used an investigational drug within 1 month before the initial screening visit
- •has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery)
- •has a known clinically significant drug sensitivity to stimulants or modafinil
研究组 & 干预措施
1
Armodafinil 250 mg/day
干预措施: Armodafinil 250 mg/day (Drug)
2
Armodafinil 150 mg/day
干预措施: Armodafinil 150 mg/day (Drug)
3
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Maintenance of Wakefulness Test (MWT)
时间窗: change from baseline at 12 weeks
The MWT is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. The primary variable was the 30 minute MWT (average of 4 naps at 0900, 1100, 1300, and 1500) assessed at the last postbaseline observation.
Clinical Global Impression of Change (CGI-C)
时间窗: change from baseline at 12 weeks
The CGI-C represents a subjective measure of the patient's global health (clinician's rating of disease severity as compared with a pretreatment evaluation as assessed by the CGI-S). The CGI-C scale (change from baseline)categories include:1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness (CGI-S) was assessed at baseline includes categories: 1=Normal; 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.
次要结局
未报告次要终点