NL-OMON47913已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Crossover On-Road Driving Study Assessing the Effect of JZP-110 on Driving Performance in Subjects with Excessive Sleepiness Due to Narcolepsy - Effect of JZP-110 on driving performance in subjects with narcolepsy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male or female, age 21 to 75 years inclusive
- •2. Diagnosis of narcolepsy per ICSD-3 or DSM-5
- •3. BMI 18 to <40 kg/m2
- •4. Use a medically acceptable method of contraception
- •5. Willing and able to provide written informed consent
排除标准
- •1. Female subjects who are pregnant, nursing, or lactating
- •2. Any other clinically relevant medical, behavioral, or psychiatric disorder
- •other than narcolepsy that is associated with excessive sleepiness
- •3. History or presence of bipolar disorder, bipolar related disorders,
- •schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders
- •according to DSM-5 criteria
- •4. History or presence of any 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
- •and/or safety assessments per the judgment of the investigator
- •5. History of bariatric surgery within the past year or a history of any
- •gastric bypass procedure
- •6. Presence of significant cardiovascular disease
- •7. Use of any over-the-counter (OTC) or prescription medications that could
- •affect sleep-wake function
研究者
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