Status:
RECRUITING
Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder
Lead Sponsor:
Idorsia Pharmaceuticals Ltd.
Conditions:
Insomnia
Eligibility:
All Genders
10-17 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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:
- Difficulty initiating or maintaining sleep, or early morning awakening with inability to return to sleep,
- Sleep difficulty has been present for at least 3 months prior to Screening,
- Sleep difficulty occurs at least 3 nights per week,
- Persistence of sleep difficulty, despite adequate sleep hygiene or non-pharmacological therapy,
- The sleep problem occurs despite adequate age appropriate time and opportunity for sleep,
- 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,
- 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:
- Negative serum pregnancy test at Screening and a negative urine pregnancy test at Randomization.
- Agreement to undertake urine pregnancy tests during the study, as per the schedule of activities and up to 5 days after study treatment discontinuation.
- 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.
Exclusion
- 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:
- 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.
- 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.
Key Trial Info
Start Date :
September 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05423717
Start Date
September 6 2022
End Date
April 1 2026
Last Update
November 5 2025
Active Locations (52)
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1
Banner - University Medical Center Tucson
Tucson, Arizona, United States, 85724
2
Preferred Research Partners NWA, LLC
Fayetteville, Arkansas, United States, 72703
3
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States, 72211
4
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027