NCT05423717已完成2 期
Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Polysomnography, Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Multiple-dose Oral Administration of Daridorexant in Pediatric Subjects Aged 10 to < 18 Years With Insomnia Disorder
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
- 166
- 试验地点
- 65
- 主要终点
- Change from baseline to Day 1 in Total Sleep Time (TST) as measured by polysomnography (PSG).
研究概览
简要总结
This study assesses the efficacy, safety, and pharmacokinetics of multiple-dose oral administration of daridorexant in pediatric subjects aged 10 to < 18 years with insomnia disorder.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent form (ICF) from the caregiver, i.e., parent/legal guardian prior to any study mandated procedure, or as per local regulation.
- •Written assent must be obtained from subjects of the appropriate age who can give assent, as determined by the caregiver and local regulation or institutional review boards / independent ethics committees.
- •Male or female subjects aged ≥ 10 and < 18 years at the time of signing the ICF.
- •Chronic insomnia disorder in accordance with International Classification of Sleep Disorders, 3rd edition (ICSD-3) or insomnia disorder in accordance with Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria at Screening, as supported by statements from the child and/or the caregiver:
- •Difficulty initiating or maintaining sleep, or early morning awakening with inability to return to sleep,
- •Sleep difficulty has been present for at least 3 months prior to Screening,
- •Sleep difficulty occurs at least 3 nights per week,
- •Persistence of sleep difficulty, despite adequate sleep hygiene or non-pharmacological therapy,
- •The sleep problem occurs despite adequate age appropriate time and opportunity for sleep,
- •The sleep problem is not due to the direct pharmacological effects of any concomitant medication (e.g., amphetamines, selective serotonin reuptake inhibitors) as per investigator judgment,
- •Self-report or caregiver report of poor sleep quality and/or quantity impacting the daytime performance of the subject,
- •Sleep Disturbance Scale for Children score > 16 on the Difficulty Initiating or Maintaining Sleep domain at Screening.
- •Adolescent of Child-Bearing Potential:
- •Negative serum pregnancy test at Screening and a negative urine pregnancy test at Randomization.
- •Agreement to undertake urine pregnancy tests during the study, as per the schedule of activities and up to 5 days after study treatment discontinuation.
- •Agreement to use an acceptable effective method of contraception from Screening up to 5 days after study treatment discontinuation.
- •Inclusion criteria applicable only to a subset of children with insomnia and comorbid neurodevelopmental disorder (NDD): Must have a documented history of NDD (including autism spectrum disorder or attention deficit hyperactivity disorder) according to DSM-5 criteria, as confirmed by review of medical records, at Screening. Use of central nervous system (CNS) stimulants is allowed if started at least 4 weeks prior to Screening, is stable, and is expected to remain stable during the study until End-of-Treatment. CNS stimulants are recommended to be taken in the morning.
排除标准
- •Body weight < 25 kg.
- •Daytime napping ≥ 1 h per day on at least 3 weekdays per week during the 3 months prior to Screening.
- •Any lifetime history of sleep-related breathing disorders such as obstructive sleep apnea, based on the subject's medical records. Note: a subject whose breathing disorder has been treated by tonsillectomy/ adenoidectomy remains eligible.
- •Any other diagnosed sleep-wake disorder as defined in DSM-5 or ICSD-3 (e.g., restless legs syndrome, circadian rhythm sleep wake disorder, parasomnias, narcolepsy) at Screening.
- •Any of the following conditions related to suicidality:
- •Any suicidal ideation with intent, with or without a plan at Screening, i.e., answering "Yes" to questions 4 or 5 on the suicidal ideation section of the lifetime (Visit 1) and visit (Visit 2) version of the Columbia Suicide Severity Rating Scale© (C-SSRS©). Participants who answer "yes" to any of these questions must be referred to the investigator for follow-up evaluation.
- •History of suicide attempt on the suicidal behavior section of the lifetime version of the C-SSRS© at Visit
- •Any acute or unstable significant medical condition (e.g., seizure disorder, bipolar disorder, schizophrenia), hematology/biochemistry test results, and/or electrocardiogram results deviating from the normal ranges to a clinically relevant extent that would preclude participation in the study or could prevent the subject from complying with study requirements, as per investigator judgement.
- •Cognitive behavior therapy for any indication is allowed only if it has been started at least 1 month prior to Visit 2 and is kept stable throughout the study.
研究组 & 干预措施
Daridorexant 10 mg
Experimental
干预措施: Daridorexant 10 mg (Drug)
Daridorexant 25 mg
Experimental
干预措施: Daridorexant 25 mg (Drug)
Daridorexant 50 mg
Experimental
干预措施: Daridorexant 50 mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline to Day 1 in Total Sleep Time (TST) as measured by polysomnography (PSG).
时间窗: PSG will be performed on 2 nights during the screening period and on Day 1 of the treatment period (total duration: 3 days).
Baseline is defined as the mean of the 2 PSG nights during the screening period.
次要结局
未报告次要终点
研究者
研究点 (65)
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