A Long-Term Safety and Maintenance of Efficacy Study ofJZP-110 [(R)-2-amino-3 Phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or Obstructive Sleep Apnea
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 645
- 试验地点
- 80
- 主要终点
- Change in Epworth Sleepiness Scale (ESS) Score
研究概览
简要总结
This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or ADX-N05 202.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject meets one of the following:
- •Completed Study 14-002 or 14-003 (Group A)
- •Completed Study 14-004, 15-004, 15-005, ADX-N05 201 or ADX-N05 202 (Group B)
- •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 narcolepsy or 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
- •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 Investigator
- •History of bariatric surgery within the past year or a history of roux-en-y 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 other than JZP-110 in the past 30 days or five half-lives (whichever is longer)
- •History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
研究组 & 干预措施
75 mg - 300 mg of JZP-110
Once Daily Dosing
干预措施: JZP-110 (Drug)
结局指标
主要结局
Change in Epworth Sleepiness Scale (ESS) Score
时间窗: Start of randomized withdrawal phase to end of randomized withdrawal (2 weeks)
Change in Epworth Sleepiness Scale (ESS) score during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. 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. This analysis included treatment group and randomization stratification factor (narcolepsy vs. OSA) as fixed effects. The ESS score at the beginning of the randomized withdrawal period was used as the covariate. The response variable was the change in ESS score from the beginning to the end of 2- week randomized withdrawal period.
次要结局
- Subjects Reported as Worse on the Patient Global Impression of Change (PGIc)(Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks))
- Subjects Reported as Worse on the Clinical Global Impression of Change (CGIc)(Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks))