NCT01096680已完成2 期
A Phase 2, Randomized, Double-Blind, Single Center, Parallel Group, Placebo and Active Comparator, Controlled Study to Evaluate the Pharmacodynamic Profile of Single Doses of SPD489 in Healthy Adult Male Subjects Undergoing a Nocturnal Period of Acute Sleep Loss
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Maintenance of Wakefulness Test (MWT)
研究概览
简要总结
This is a double-blind, single center, parallel group, placebo and active comparator, controlled study to characterize the wake promoting effects of single doses of SPD489 in healthy adult male undergoing acute sleep deprivation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subjects between the ages of 18-40 years.
- •The subject is in good health and must have a satisfactory medical assessment with no clinically significant and relevant abnormalities (of medical history, physical examination, electrocardiogram (ECG), clinical laboratory evaluation (hematology, biochemistry, and urinalysis).
- •Subject has a history of regular sleep-wake habits, routinely spending 6.5-8 hours in bed nightly, and does not oversleep by more than 3 hours on weekends.
- •Subject has the ability to provide written, signed, and dated (personally) informed consent to participate in the study, in accordance with the International Conference on Harmonisation Good Clinical Practice Guideline E6 and applicable regulations, before completing any study-related procedures.
排除标准
- •Current or relevant previous history of serious, severe, or unstable (acute or progressive) physical or psychiatric illness, any medical disorder that may require treatment or make this subject unlikely to fully complete the study, or any condition that presents undue risk from SPD489 or armodafinil or procedures. Comorbid psychiatric diagnosis will be established by a psychiatric evaluation that includes the Mini International Neuropsychiatric Interview (MINI)-Plus.
- •Subject is currently considered a suicide risk, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating suicidal ideation.
- •Subject has a known or suspected sleep disorder, or another disorder associated with excessive daytime sleepiness, or any other diagnosis that would interfere with assessing sleepiness in subjects with study related induced sleepiness or abnormal findings on the initial PSG conducted on Day -1 such as, but not limited to, Apnea-Hypopnea Index (AHI) or Periodic Limb Movement Arousal Index (PLMAI) >10.
研究组 & 干预措施
SPD489 20 mg
Experimental
干预措施: SPD489 20 mg (Drug)
SPD489 50 mg
Experimental
干预措施: SPD489 50 mg (Drug)
SPD489 70 mg
Experimental
干预措施: SPD489 70 mg (Drug)
Armodafinil
Active Comparator
干预措施: Armodafinil (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Maintenance of Wakefulness Test (MWT)
时间窗: Over a period of 8 hours
The MWT was conducted to determine the subjects' ability to stay awake. Subjects sat in a darkened room and were told to "stay awake as long as possible" during the 30 minute session. This is an indicator of how well you are able to function and remain alert in quiet times of inactivity. Higher times are better.
次要结局
- Psychomotor Vigilance Task (PVT) Scores(Over a period of 12 hours)
- Karolinska Sleepiness Scale (KSS) Scores(Over a period of 15 hours)
- PVT Scores by Timepoint(Over a period of 12 hours)
- KSS Scores by Timepoint(Over a period of 15 hours)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study to Investigate Safety, Tolerability and Clinical Response With SAR441566 Compared With Placebo in Participants With Mild to Moderate PsoriasisPsoriasisNCT05453942Sanofi38
已完成
2 期
A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic FibrosisCystic FibrosisNCT02951195Vertex Pharmaceuticals Incorporated80
已完成
2 期
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)Rheumatoid ArthritisNCT02833350Genentech, Inc.578
已完成
2 期
A Study to Evaluate the Efficacy and Safety of X0002 Spray in Subjects With OsteoarthritisOsteoarthritis of the KneeNCT02067611Lina Xu216
已完成
2 期
A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisCystic FibrosisNCT02951182Vertex Pharmaceuticals Incorporated74