A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, 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 Narcolepsy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 239
- 试验地点
- 59
- 主要终点
- Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12
研究概览
简要总结
This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter, 4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy.
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
- •Males and females between 18 and 75 years of age, inclusive
- •Diagnosis of narcolepsy according to ICSD-3 or DSM-5 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
- •Moderate or severe sleep apnea on the baseline PSG.
- •Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy 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, safety, PK assessments, or the ability of the subject to complete the trial per the judgment of the Investigator
- •History of bariatric surgery within the past year or a history of any gastic 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
- •Use of any medications that could affect the evaluation of cataplexy
- •Received an investigational drug in the past 30 days or five half-lives (whichever is longer)
- •Previous exposure to or participation in a previous clinical trial of JZP-110 (ADX-N05, R228060, YKP10A)
- •History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
研究组 & 干预措施
75 mg of JZP-110
Once Daily Dosing
干预措施: JZP-110 (Drug)
150 mg JZP-110
Once Daily Dosing
干预措施: JZP-110 (Drug)
300 mg of JZP-110
Once Daily Dosing
干预措施: JZP-110 (Drug)
Placebo
Once Daily Dosing
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12
时间窗: Baseline to Week 12
Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to Week 12. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake; a positive change from baseline represents improvement in the sleep latency time. Mean sleep latency defined as the average of the first 4 MWT trials, if 3 or 4 of them are non-missing.
Change in ESS Score From Baseline to Week 12
时间窗: Baseline to Week 12
Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 12. 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 baseline.
次要结局
- Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12(Baseline to Week 12)
- Change in Sleep Latency Time on MWT Trial 1 at Week 12(Change from baseline for sleep latency in MWT during trial 1 at week 12)
- Change in Sleep Latency Time on MWT Trial 2 at Week 12(Change from baseline for sleep latency in MWT during trial 2 at week 12)
- Change in Sleep Latency Time on MWT Trial 3 at Week 12(Change from baseline for sleep latency in MWT during trial 3 at week 12)
- Change in Sleep Latency Time on MWT Trial 4 at Week 12(Change from baseline for sleep latency in MWT during trial 4 at week 12)
- Change in Sleep Latency Time on MWT Trial 5 at Week 12(Change from baseline for sleep latency in MWT during trial 5 at week 12)
- Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-Minute MWT From Baseline to Week 4(Baseline to Week 4)