BMJ open · 2026
Daridorexant in children and adolescents with insomnia disorder: study protocol for a multicentre randomised controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод пока не подготовлен
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Coloma Preciosa, Coury Daniel, Wernette Sophie, Beevers Vicki, Dubois Cécile, Di Marco Tobias, Dursun Ozan Taylan, Bruni Oliviero
Аннотация
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 study also assesses the safety, tolerability, pharmacokinetics, palatability and acceptability of daridorexant.
ETHICS AND DISSEMINATION: This study has been approved by the respective health authorities and institutional review boards/independent ethics committees for each participating site and country and is conducted in accordance with the Declaration of Helsinki. Ethics approval has been obtained for each participating country/site. Regardless of the outcomes, the results will be published in an international peer-reviewed scientific journal.
TRIAL REGISTRATION NUMBER: NCT05423717.
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 study also assesses the safety, tolerability, pharmacokinetics, palatability and acceptability of daridorexant.
ETHICS AND DISSEMINATION: This study has been approved by the respective health authorities and institutional review boards/independent ethics committees for each participating site and country and is conducted in accordance with the Declaration of Helsinki. Ethics approval has been obtained for each participating country/site. Regardless of the outcomes, the results will be published in an international peer-reviewed scientific journal.
TRIAL REGISTRATION NUMBER: NCT05423717.
Предметные рубрики MeSH
HumansSleep Initiation and Maintenance DisordersChildAdolescentDouble-Blind MethodFemaleMaleMulticenter Studies as TopicOrexin Receptor AntagonistsPyrrolidinesRandomized Controlled Trials as TopicClinical Trials, Phase II as TopicAttention Deficit Disorder with HyperactivityTreatment OutcomeDose-Response Relationship, DrugImidazoles