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 enrollmentJuly 11, 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: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 11, 2022

End Date

TBD

Last Updated

3 years ago

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.