NCT02806908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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Standard Deviation of Lateral Position (SDLP) at 2 Hours Post-dose (Approximately at Tmax)
研究概览
简要总结
This trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate the effect of JZP-110 on driving performance in subjects with excessive sleepiness due to narcolepsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 21 to 65 years inclusive
- •Diagnosis of narcolepsy per International Classification of Sleep Disorders (ICSD-3) or Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5)
- •BMI 18 to <40 kg/m2
- •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
- •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 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
- •History of bariatric surgery within the past year or a history of any gastric bypass procedure
- •Presence or history of significant cardiovascular disease
- •Unable to washout or refrain from taking any over-the-counter (OTC) or prescription medications that could affect sleep-wake function
研究组 & 干预措施
Placebo
Placebo Comparator
Once daily dosing
干预措施: Placebo (Drug)
JZP-110
Active Comparator
150 mg/day for first 3 days and 300 mg/day for next 4 days
干预措施: JZP-110 (Drug)
结局指标
主要结局
Standard Deviation of Lateral Position (SDLP) at 2 Hours Post-dose (Approximately at Tmax)
时间窗: 2 hours post-dose
Subjects were instructed to drive with steady lateral position between the delineated boundaries of the slower (right) traffic lane, while maintaining a constant speed of 95 kilometers (km) per hour (hr). Deviation was measured by the vehicle's speed and lateral distance to the left lane line and was continuously recorded. Individual improvement was defined as a decrease in SDLP below the negative value of threshold; individual impairment was defined as an increase in SDLP above the threshold or failure to complete the driving test due to sleepiness or subjects related safety concerns.
次要结局
- Number of Subjects With Improved or Impaired Driving at a Threshold 3.0 cm on JZP-110 Compared to Placebo 6 Hours Post-dose(6 hours post-dose)
- Number of Subjects With Improved or Impaired Driving at a Threshold 3.5 cm on JZP-110 Compared to Placebo 6 Hours Post-dose(6 hours post-dose)
- Standard Deviation of Speed (SDS) at 2 Hours Post-dose(2 hours post-dose)
- SDS at 6 Hours Post-dose(6 hours post-dose)
- Number of Subjects With Improved or Impaired Driving at a Threshold 3.0 cm on JZP-110 Compared to Placebo 2 Hours Post-dose(2 hours post-dose)
- Number of Subjects With Improved or Impaired Driving at a Threshold 1.5 cm on JZP-110 Compared to Placebo 6 Hours Post-dose(6 hours post-dose)
- Number of Subjects With Improved or Impaired Driving at a Threshold 2.5 cm on JZP-110 Compared to Placebo 6 Hours Post-dose(6 hours post-dose)
- PVT Number of Lapses at 6 Hours Post-dose(6 hours post-dose)
- SDLP at 6 Hours Post-dose(6 hours post-dose)
- Number of Subjects With Improved or Impaired Driving at a Threshold 1 Centimeter (cm) on JZP-110 Compared to Placebo 2 Hours Post-dose(2 hours post-dose)
- Number of Subjects With Improved or Impaired Driving at a Threshold 1.5 cm on JZP-110 Compared to Placebo 2 Hours Post-dose(2 hours post-dose)
- Number of Subjects With Improved or Impaired Driving at a Threshold 2.5 cm on JZP-110 Compared to Placebo 2 Hours Post-dose(2 hours post-dose)
- Number of Subjects With Improved or Impaired Driving at a Threshold 3.5 cm on JZP-110 Compared to Placebo 2 Hours Post-dose(2 hours post-dose)
- Number of Subjects With Improved or Impaired Driving at a Threshold 1 cm on JZP-110 Compared to Placebo 6 Hours Post-dose(6 hours post-dose)
- Number of Lapses in Driving Test at 6 Hours Post-dose(6 hours post-dose)
- Number of Subjects With Improved or Impaired Driving at a Threshold 2.0 cm on JZP-110 Compared to Placebo 6 Hours Post-dose(6 hours post-dose)
- PVT Mean Reaction Time at 2 Hours Post-dose(2 hours post-dose)
- PVT Mean Reaction Time at 6 Hours Post-dose(6 hours post-dose)
- PVT Inverse Reaction Time at 2 Hours Post-dose(2 hours post-dose)
- PVT Inverse Reaction Time at 6 Hours Post-dose(6 hours post-dose)
- PVT Number of Errors of Commission at 2 Hours Post-dose(2 hours post-dose)
- PVT Number of Errors of Commission at 6 Hours Post-dose(6 hours post-dose)
- Toronto Hospital Alert Test (THAT)(Post Treatment at day 21)
- Number of Subjects With Improved or Impaired Driving at a Threshold 2.0 cm on JZP-110 Compared to Placebo 2 Hours Post-dose(2 hours post-dose)
- Number of Lapses in Driving Test at 2 Hours Post-dose(2 hours post-dose)
- Psychomotor Vigilance Test (PVT) Number of Lapses at 2 Hours Post-dose(2 hours post-dose)
研究者
研究点 (1)
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