NCT00857220已完成3 期
A Long Term, Open-Label, Safety Study of Eszopiclone in Children (6 to 11 Years) and Adolescents (12 to 17 Years) With Attention Deficit/Hyperactivity Disorder Associated Insomnia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 85
- 主要终点
- Overall Incidence of Adverse Events
研究概览
简要总结
A multicenter study to evaluate the safety of eszopiclone 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, open label, long term safety study in pediatric subjects 6 through 17 years of age, inclusive, with a diagnosis of ADHD associated insomnia. Subjects who complete Study 190 246 (Rollover subjects) and meet the study enrollment criteria will be allowed to participate in this long term safety study. Additionally, Treatment naïve subjects will be enrolled in this long term safety study in order to meet the overall subject enrollment objective of obtaining 100 subjects with 12 months of treatment. 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
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Inclusion Criteria:
- •Subject is male or female 6 17 years of age, inclusive, at the time of consent.
- •Subject must have a diagnosis of ADHD as defined by DSM-IV criteria • The diagnosis for Rollover subjects will be taken from the Screening visit of Study 190
- •Treatment naïve subjects will have these assessments performed at the Screening visit.
- •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 has either >30 minutes latency to persistent sleep (LPS) or >45 minutes wake time after sleep onset (WASO) demonstrated by PSG.
- •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 at screening
- •Subject must be in good general health.
- •Subject must be able to swallow tablets.
- •If subjects are currently taking medication for ADHD, they must be on a stable dose and regimen for at least one month, and preferably for at least 3 months 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 abnormality/illness
- •Subject has a documented history of Bipolar I or II Disorder, major depression, conduct disorder, generalized anxiety disorder (other than obsessive-compulsive disorder) or any history of psychosis, as determined by medical or psychiatric history or as determined by clinical interview using the MINI-Kid at Visit
- •Subject has periodic limb movement >5 times per hour, as demonstrated on PSG.
- •Subject has sleep disordered breathing, as demonstrated on PSG.
- •Subject has another primary sleep disorder (or secondary sleep disorder that is causing clinical impairment 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, lactating or planning to become pregnant.
- •Subject is taking any psychotropic or disallowed medications,
- •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
- •Subject has participated in any investigational study within 30 days prior to study entry or is currently participating in another clinical trial, except Study 190 246.
研究组 & 干预措施
2mg eszopiclone (6-11yrs), 3mg eszopiclone (12-17yrs)
Experimental
干预措施: eszopiclone (Drug)
结局指标
主要结局
Overall Incidence of Adverse Events
时间窗: 12 Months (from the 1st dose to the end of study)
次要结局
- Overall Incidence of Skin Reactions: Number of Events(12 Months (from the 1st dose to the end of study))
- Overall Incidence of Skin Reactions: Number of Participant Affected(12 Months (from the 1st dose to the end of study))
- Columbia-Suicide Severity Rating Scale (C-SSRS) Item Responses(12 Months)
- Change From Baseline at Month 12 in Subjective Number of Awakening After Sleep Onset (NAASO)(Baseline and 12 Months (from the 1st dose to the end of study))
- Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS)at Month 12(Baseline and 12 Months (from the 1st dose to the end of study))
- Change From Baseline in Conners' Continuous Performance Test II (CCPT II)(Baseline and 12 Months (from the 1st dose to the end of study))
- Clinical Global Impression (CGI) Improvement Score as Assessed by Parent/Caregiver or Child at Month 12(Baseline and 12 Months (from the 1st dose to the end of study))
- Change From Baseline in Coding Copy Subtest A or B, or Digit Symbol Substitution Test (DSST)at Month 12(Baseline and 12 Months (from the 1st dose to the end of study))
- Change From Baseline at Month 12 in Subjective Sleep Latency (SL)(Baseline and 12 Months (from the 1st dose to the end of study))
- Change From Baseline at Month 12 in Subjective Total Sleep Time (TST).(Baseline and 12 Months (from the 1st dose to the end of study))
- Change From Baseline in Child Behavior Checklist (CBCL)(Baseline and 12 Months (from the 1st dose to the end of study))
- Change From Baseline at Month 12 in Subjective Wake Time After Sleep Onset (WASO)(Baseline and 12 Months (from the 1st dose to the end of study))
- Change From Baseline in Pediatric Quality of Life Scale(Baseline and 12 Months (from the 1st dose to the end of study))
研究者
研究点 (85)
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