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

Idorsia Pharmaceuticals Ltd0 sites150 target enrollmentDecember 6, 2022

ConditionsInsomnia Disorder Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

DrugsQUVIVIQ

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Insomnia Disorder
Sponsor: Idorsia Pharmaceuticals Ltd
Enrollment: 150
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 6, 2022

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Idorsia Pharmaceuticals Ltd

Eligibility Criteria

Inclusion Criteria

•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,

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:
•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.