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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.
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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:
Sleep Disturbance Scale for Children (SDSC) score > 16 on the Difficulty Initiating or Maintaining Sleep domain at Screening.
Adolescent of Child-Bearing Potential (AoCBP):
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 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.
Primary purpose
Allocation
Interventional model
Masking
150 participants in 4 patient groups, including a placebo group
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Idorsia Clinical Trials Information
Data sourced from clinicaltrials.gov
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