Daridorexant in children and adolescents with insomnia disorder: study protocol for a multicentre randomised controlled trial
Abstract
Introduction: Insomnia disorder imposes a significant burden on children and adolescents; however, treatment options are limited. This paper describes the first controlled study to investigate the efficacy and safety of daridorexant, a dual orexin receptor antagonist, in children and adolescents with or without comorbid neurodevelopmental disorders, allowing its evaluation in a broad paediatric population.
Methods and analysis: This multicentre, double-blind, randomised, placebo-controlled, parallel-group, dose-finding Phase 2 trial includes male and female participants aged ≥10 to <18 years meeting the diagnosis of insomnia disorder as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) or International Classification of Sleep Disorders, Third Edition (ICSD-3) criteria. The study population is stratified into three groups: those with a known diagnosis of autism spectrum disorder (ASD) or attention-deficit hyperactivity disorder (ADHD); those without a diagnosis of ASD/ADHD but who meet the definition of 'subthreshold ASD' or 'subthreshold ADHD'; those with neither diagnosed ASD/ADHD nor 'subthreshold' ASD/ADHD. Study participants are randomised 1:1:1:1 to daridorexant 10 mg, 25 mg, 50 mg or placebo for at least 14 days. The change from baseline to Day 1 in total sleep time, measured by polysomnography, is the primary endpoint used to characterise the dose-response relationship of daridorexant in paediatric subjects with insomnia disorder. The…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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