A Six-Week, Double-Blind, Placebo-Controlled, Randomized- Withdrawal, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Obstructive Sleep Apnea (OSA)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 30
- 主要终点
- Change in the Maintenance of Wakefulness Test (MWT)
研究概览
简要总结
This trial is a 6-week, double-blind, placebo-controlled, randomized-withdrawal, multicenter study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between 18 and 75 years of age, inclusive
- •Diagnosis of OSA according to ICSD-3 criteria
- •Body mass index from 18 to <45 kg/m2
- •Consent to use a medically acceptable method of contraception
- •Willing and able to provide written informed consent
排除标准
- •Female subjects who are pregnant, nursing, or lactating.
- •Any other clinically relevant medical, behavioral, or psychiatric disorder other than OSA that is associated with excessive sleepiness
- •History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
- •History or presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy or safety assessments or the ability of the subject to complete the trial per the judgment of the principal investigator
- •History of bariatric surgery within the past year or a history of any gastric bypass procedure
- •Presence or history of significant cardiovascular disease
- •Use of any over the counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
- •Received an investigational drug in the past 30 days or five half-lives (whichever is longer)
- •Previous exposure to or participation in a clinical trial of JZP-110 (ADX-N05, R228060, or YKP10A)
- •History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
研究组 & 干预措施
75, 150, 300 mg of JZP-110
Once Daily Dosing
干预措施: JZP-110 (Drug)
Placebo
Once Daily Dosing
干预措施: JZP-110 (Drug)
结局指标
主要结局
Change in the Maintenance of Wakefulness Test (MWT)
时间窗: Week 4 to Week 6
Change in the mean sleep latency time as determined from the first four trials of a 40-minute MWT from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. Mean sleep latency defined as the average of the first four MWT trial's measurements.
Change in the Epworth Sleepiness Scale (ESS)
时间窗: Week 4 to Week 6
Change in Epworth Sleepiness Scale (ESS) score from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. A negative change from baseline represents improvement in excessive sleepiness. The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from week 4 to week 6.
次要结局
- Patient Global Impression of Change (PGIc)(Week 4 to Week 6)
- Clinical Global Impression of Change (CGIc)(Week 4 to Week 6)
- Change in Functional Outcomes of Sleep Questionnaire (FOSQ-10)(Week 4 to Week 6)