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

  • STATUS
    Recruiting
  • End date
    Apr 27, 2024
  • participants needed
    150
  • sponsor
    Idorsia Pharmaceuticals Ltd.
Updated on 25 October 2022
selective serotonin reuptake inhibitors
poor sleep
chronic insomnia
terminal insomnia

Summary

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.

Details
Condition Insomnia
Treatment Placebo, Daridorexant 10 mg, Daridorexant 25 mg, Daridorexant 50 mg
Clinical Study IdentifierNCT05423717
SponsorIdorsia Pharmaceuticals Ltd.
Last Modified on25 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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 (SDSC) score > 16 on the Difficulty Initiating or
Maintaining Sleep domain at Screening
Adolescent of Child-Bearing Potential (AoCBP)
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: 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

Exclusion Criteria

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 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 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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