A Randomized, Placebo Controlled, Double Blind, Fixed Dose Study of the Efficacy and Safety of Eszopiclone in Children (6 to 11 Years) and Adolescents (12 to 17 Years) With Attention Deficit/Hyperactivity Disorder Associated Insomnia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 486
- 试验地点
- 69
- 主要终点
- Change From Baseline to the End of the Double- Blind Treatment Period (Week 12) in Polysomnography (PSG) Defined Latency to Persistent Sleep (LPS).
研究概览
简要总结
A multi center, randomized study to evaluate the efficacy and safety of eszopiclone compared to placebo in children (6-11 years of age, inclusive) and adolescents (12-17 years of age, inclusive) with attention deficit/hyperactivity disorder (ADHD) associated insomnia.
详细描述
This is a multi center, randomized, double blind, placebo controlled, fixed dose study of eszopiclone in pediatric subjects 6-17 years of age, inclusive, with ADHD associated insomnia. Subjects will be randomized at approximately 1:1:1 to either low dose oral eszopiclone (1 mg for children ages 6-11 years, 2 mg for adolescents ages 12-17 years), high dose oral eszopiclone (2 mg for children ages 6-11 years, 3 mg for adolescents ages 12-17 years) or placebo. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is male or female 6 to 17 years of age, inclusive, at the time of consent.
- •Subject must have a diagnosis of ADHD as defined by DSM-IV criteria
- •Subject must have documented ADHD associated insomnia, defined as the subject or subject's parent/legal guardian having reported repeated difficulty with sleep initiation (sleep latency >30 minutes) or consolidation, (wake time after sleep onset >45 minutes) despite adequate age appropriate time and opportunity for sleep.
- •Subject's Baseline PSG must reveal either >30 minutes latency to persistent sleep (LPS) or >45 minutes wake after sleep onset (WASO).
- •Subject or subject's parent/legal guardian should have reported daytime functional impairment as a result of sleep problems.
- •Subject or subject's parent/legal guardian should have reported attempted and failed behavioral interventions for sleep problems, including a regular bedtime and rise time
- •Subject's sleep disturbance must not be attributable to either the direct physiologic effect of a drug of abuse or misuse of a prescribed medication whether it is being used as intended or in an illicit manner.(Female subjects ≥8 years of age must have a negative serum pregnancy test)
- •Subject must be in general good health
- •Subject must be able to swallow tablets.
- •If subject is currently taking medication for ADHD, they must be on a stable dose and regimen for a minimum of 1 month prior to the time of consent
排除标准
- •Subject with weight <10th percentile for age and gender
- •Subject has any clinically significant or unstable medical illness/abnormality or chronic disease.
- •Subject has a documented history of Bipolar I or II Disorder, major depression, conduct disorder, generalized anxiety disorder or any history of psychosis.
- •Subject has periodic limb movement >5 times per hour, as demonstrated on Baseline PSG.
- •Subject has sleep disordered breathing, as demonstrated on Baseline PSG.
- •Subject has another primary sleep disorder, a secondary sleep disorder, or any other known or suspected medical or psychiatric condition that has affected or may affect sleep
- •Subject has a history of circadian rhythm disorder or will travel across ≥3 time zones more than once during the study.
- •Subject has organic brain disease, or a history of febrile seizures.
- •Subject is, in the opinion of the investigator, at suicidal or homicidal risk.
- •Female subject who is pregnant or lactating or planning to become pregnant.
- •Subject has taken any psychotropic medication without an appropriate washout period (≥5 half-lives) prior to randomization.
- •Subject has a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.
- •Subject has a history of allergic reaction or has a known or suspected sensitivity to racemic zopiclone, eszopiclone, or any substance that is contained in the formulation.
- •Subject has a history of alcohol or substance abuse within 3 months of study participation.
研究组 & 干预措施
Low dose eszopiclone
1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
干预措施: eszopiclone (Drug)
High dose eszopiclone
2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
干预措施: eszopiclone (Drug)
Placebo
Placebo 6-17 years
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to the End of the Double- Blind Treatment Period (Week 12) in Polysomnography (PSG) Defined Latency to Persistent Sleep (LPS).
时间窗: Baseline (Day 0) to Week 12
A central scoring facility was used to derive the PSG sleep parameters Latency to Persistent Sleep (LPS) from the epochs and stages collected via the PSG recordings. Each epoch is 30 seconds. The PSG parameters provided an objective assessment of the subject's sleep on a given night. Change from BL at Week 12 in LPS was derived from Week 12 LPS subtracted by BL LPS. Latency to persistent sleep (LPS; minutes): time from lights out to the first of 20 consecutive epochs (10 minutes) of non-wake, as determined by PSG recordings.
次要结局
- Change From Baseline (Day 0) to Week 12 in PSG Defined Wake Time After Sleep Onset (WASO)(Baseline (Day 0) to Week 12)
- Change From Baseline in Clinical Global Improvement (CGI)-Parent/Caregiver at Week 12(Baseline (Day 0) to Week 12)
- Change From Baseline in CGI-Child at Week 12(Baseline (Day 0) to Week 12)
- Change From Baseline (Day 0) to Week 12 in Conners' ADHD Inattention Rating Scale.(Baseline (Day 0) to Week 12)
- Change From Baseline to Week 12 in Subjective SL (Sleep Latency)(Baseline (Day 0) to Week 12)
- Change From Baseline to Week 12 in Subjective Wake Time After Sleep Onset (WASO).(Baseline (Day 0) to Week 12)
- Change From Baseline to Week 12 in PSG Defined Sleep Efficiency (SE)(Baseline (Day 0) to Week 12)
- Change From Baseline to Week 12 in PSG Defined Number of Awakenings After Sleep Onset (NAASO).(Baseline (Day 0) to Week 12)
- Change From Baseline to Week 12 in PSG Defined Total Sleep Time (TST)(Baseline (Day 0) to Week 12)
- Change From Baseline to Week 12 in Subjective Total Sleep Time (TST).(Baseline (Day 0) to Week 12)
- Change From Baseline to Week 11 in Subjective Sleep Latency (SL) Measured by Actigraphy Monitoring in the Actigraphy Population.(Baseline (Day 0) to Week 11)
- Change From Baseline to Week 11 in Subjective WASO From Actigraphy Population.(Baseline (Day 0) to Week 11)
- Change From Baseline to Week 11 in Total Sleep Time (TST) Measured by Actigraphy Monitoring in the Actigraphy Population.(Baseline (Day 0) to Week 11)
- Change From Baseline to Week 12 in Pediatric Daytime Sleepiness Scale (PDSS) Total Score.(Baseline (Day 0) to Week 12)
- Change From Baseline to Week 12 in Coding Copy Subtest / Digit Symbol Substitution Test (DSST) Scaled Score.(Baseline (Day 0) to Week 12)
- Change From Baseline to Week 12 in Pediatric Quality-of-Life Scale (Short Form-10).(Baseline (Day 0) to Week 12)
- Change From Baseline to Week 12 in Subjective Number of Awakenings After Sleep Onset (NAASO).(Baseline (Day 0) to Week 12)
- Change in School Tardiness/Attendance Reports at Week 12 (Days)(Baseline (Day 0) to Week 12)
- Change in School Tardiness/Attendance Reports at Week 12 (Hours)(Baseline (Day 0) to Week 12)