EUCTR2021-003867-87-DE进行中（未招募）1 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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion Criteria applicable to all subjects:
- •- 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 (IRBs) / independent ethics committees (IECs).
- •- 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 (ICSD), 3rd edition or insomnia disorder in accordance with DSM-5 criteria at Screening, as supported by statements from the child and/or the caregiver:
- •1) Difficulty initiating or maintaining sleep, or early morning awakening with inability to return to sleep,
- •2) Sleep difficulty has been present for at least 3 months prior to Screening,
- •3) Sleep difficulty occurs at least 3 nights per week,
- •4) Persistence of sleep difficulty, despite adequate sleep hygiene or non-pharmacological therapy,
- •5) The sleep problem occurs despite adequate age appropriate time and opportunity for sleep,
- •6) 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,
- •7) Self-report or caregiver report of poor sleep quality and/or quantity impacting the daytime performance of the subject,
- •- Sleep Disturbance Scale for Children (SDSC) score > 16 on the Difficulty Initiating or Maintaining Sleep domain at Screening.
- •- Adolescent of Child-Bearing Potential (AoCBP):
- •1) Negative serum pregnancy test at Screening and a negative urine pregnancy test at Randomization.
- •2) Agreement to undertake urine pregnancy tests during the study, as per the schedule of activities and up to 5 days after study treatment discontinuation.
- •3) 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:
- •- Must have a documented history of NDD (including ASD or ADHD) according to DSM-5 criteria, as confirmed by review of medical records, at Screening. Use of CNS stimulants is allowed if started at least 4 weeks prior to Screening, stable and expected to remain stable during the study until EOT. CNS stimulants are recommended to be taken in the morning.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 150
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
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:
- •1) 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 C-SSRS©. Participants who answer yes” to any of these questions must be referred to the investigator for follow-up evaluation.
- •2) History of suicide attempt on the suicidal behavior section of the lifetime version of the C-SSRS© at Visit 1.
- •- Any acute or unstable significant medical condition (e.g., seizure disorder, bipolar disorder, schizophrenia), hematology/biochemistry test results, ECG 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 (CBT) 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.
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