EUCTR2015-003931-36-DE进行中（未招募）1 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 - Narcolepsy Driving Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
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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