ACTIVE_NOT_RECRUITING

Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-09-06

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05423717

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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 / independent ethics committees. * 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, 3rd edition (ICSD-3) or insomnia disorder in accordance with Diagnostic and Statistical Manual of Mental Disorders, 5th edition (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, 6. The sleep problem is not due to the direct pharmacological effects of any concomitant medication (e.g., amphetamines, selective serotonin reuptake inhibitors) as per investigator judgment, 7. Self-report or caregiver report of poor sleep quality and/or quantity impacting the daytime performance of the subject, * Sleep Disturbance Scale for Children score \> 16 on the Difficulty Initiating or Maintaining Sleep domain at Screening. * Adolescent of Child-Bearing Potential: 1. Negative serum pregnancy test at Screening and a negative urine pregnancy test at Randomization. 2. Agreement to undertake urine pregnancy tests during the study, as per the schedule of activities and up to 5 days after study treatment discontinuation. 3. Agreement to use an acceptable effective method of contraception from Screening up to 5 days after study treatment discontinuation. * Inclusion criteria applicable only to a subset of children with insomnia and comorbid neurodevelopmental disorder (NDD): Must have a documented history of NDD (including autism spectrum disorder or attention deficit hyperactivity disorder) according to DSM-5 criteria, as confirmed by review of medical records, at Screening. Use of central nervous system (CNS) stimulants is allowed if started at least 4 weeks prior to Screening, is stable, and is expected to remain stable during the study until End-of-Treatment. CNS stimulants are recommended to be taken in the morning.	* 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 Columbia Suicide Severity Rating Scale© (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, and/or electrocardiogram 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 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.

Inclusion Criteria

Exclusion 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 / independent ethics committees.
* 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, 3rd edition (ICSD-3) or insomnia disorder in accordance with Diagnostic and Statistical Manual of Mental Disorders, 5th edition (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,
6. The sleep problem is not due to the direct pharmacological effects of any concomitant medication (e.g., amphetamines, selective serotonin reuptake inhibitors) as per investigator judgment,
7. Self-report or caregiver report of poor sleep quality and/or quantity impacting the daytime performance of the subject,
* Sleep Disturbance Scale for Children score \> 16 on the Difficulty Initiating or Maintaining Sleep domain at Screening.
* Adolescent of Child-Bearing Potential:
1. Negative serum pregnancy test at Screening and a negative urine pregnancy test at Randomization.
2. Agreement to undertake urine pregnancy tests during the study, as per the schedule of activities and up to 5 days after study treatment discontinuation.
3. Agreement to use an acceptable effective method of contraception from Screening up to 5 days after study treatment discontinuation.
* Inclusion criteria applicable only to a subset of children with insomnia and comorbid neurodevelopmental disorder (NDD): Must have a documented history of NDD (including autism spectrum disorder or attention deficit hyperactivity disorder) according to DSM-5 criteria, as confirmed by review of medical records, at Screening. Use of central nervous system (CNS) stimulants is allowed if started at least 4 weeks prior to Screening, is stable, and is expected to remain stable during the study until End-of-Treatment. CNS stimulants are recommended to be taken in the morning.

* 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 Columbia Suicide Severity Rating Scale© (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, and/or electrocardiogram 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 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.

Contacts and Locations

Principal Investigator

Clinical Trials

STUDY_DIRECTOR

Idorsia Pharmaceuticals Ltd.

Study Locations (Sites)

Banner - University Medical Center Tucson

Tucson, Arizona, 85724

United States

Preferred Research Partners, Inc.

Little Rock, Arkansas, 72211

United States

Teradan Clinical Trials

Brandon, Florida, 33511

United States

D&H National Research Centers, Inc.

Miami, Florida, 33155

United States

Hope Research Network

Miami, Florida, 33166

United States

University of South Florida - Tampa General Hospital (TGH)

Tampa, Florida, 33606

United States

Encore Medical Research of Weston

Weston, Florida, 33331

United States

Florida Pediatric Research Institute

Winter Park, Florida, 32789

United States

NeuroTrials Research, Inc.

Atlanta, Georgia, 30328

United States

Clinical Research Institute

Stockbridge, Georgia, 30281

United States

Bogan Sleep Consultants, LLC

Columbia, South Carolina, 29201

United States

National Clinical Research, Inc

Richmond, Virginia, 23294

United States

Collaborators and Investigators

Sponsor: Idorsia Pharmaceuticals Ltd.

Clinical Trials, STUDY_DIRECTOR, Idorsia Pharmaceuticals Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-06

Study Completion Date2026-04

Study Record Updates

Study Start Date2022-09-06

Study Completion Date2026-04

Terms related to this study

Additional Relevant MeSH Terms

Insomnia