A Four-week, Double-blind, Placebo-controlled, Randomized, Multicenter, Parallel-group Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in Adults for the Treatment of Narcolepsy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 22
- 主要终点
- Change in ESS Score From Baseline to Week 4
研究概览
简要总结
This is a double-blind, randomized, placebo-controlled, multicenter trial of NLS-2 in adult patients with narcolepsy. The study will enroll approximately 60 patients and eligible patients will be treated to receive either NLS-2 or placebo for 4-weeks.
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
- •Males and females between 18 and 65 years of age, inclusive
- •Diagnosis of narcolepsy according to ICSD-3 (International Classification of Sleep Disorders, 3rd Edition) or Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria
- •Body mass index from 18 to 40 kg/m2, inclusive
- •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 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
- •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)
研究组 & 干预措施
NLS-2 (mazindol extended release)
2 mg dosed orally, once daily for 1 week; followed by 3 mg dosed orally, once daily for up to 3 weeks (total of 4 weeks)
干预措施: mazindol extended release (Drug)
Placebo
Dosed orally, once daily for up to 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change in ESS Score From Baseline to Week 4
时间窗: Baseline to Week 4
Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 4. 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.
次要结局
- Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 4(Baseline to Week 4)