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

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

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.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Drug: Daridorexant 10 mg; Drug: Daridorexant 25 mg; Drug: Daridorexant 50 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Kozloduy, Bulgaria, 3320
    • MC Zdrave 1 Ltd.
  • Pleven, Bulgaria, 508
    • MHAT "Heart and Brain" (SJSC)
  • Plovdiv, Bulgaria, 4001
    • University Hospital (UMHAT) Sveti Georgi
  • Razgrad, Bulgaria, 7200
    • MC ReSpiro Ltd.
  • Sofia, Bulgaria, 1680
    • MC Kalimat
  • Sofia, Bulgaria, 1618
    • MC Sun I Zdrave ("Sleep and health") Ltd.
  • Sofia, Bulgaria, 1784
    • MC Inspiro
  • Varna, Bulgaria, 9000
    • MC Sanamedik Ltd.
• Germany
  • Berlin, Germany, 10117
    • Advanced Sleep Research Berlin GmbH
  • Berlin, Germany, 12203
    • Charité -Universitätsmedizin Berlin
  • Datteln, Germany, 45711
    • Vestische Caritas-Kliniken GmbH, Vestische Kinder- und Jugendklinik Datteln
  • München, Germany, 80333
    • ProSomno
  • Schwerin, Germany, 19053
    • SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
• Italy
  • Bologna, Italy, 40139
    • IRCCS Ospedale Bellaria
  • Florence, Italy, 50139
    • Meyer Children's Hospital
  • Genova, Italy, 16147
    • Institute Giannina Gaslini
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebrón
  • Barcelona, Spain, 08041
    • Hospital De La Santa Creu I Sant Pau
  • Móstoles, Spain, 28938
    • HM Puerta del Sur, Unidad del Sueño
  • Valencia, Spain, 46010
    • Hospital Quironsalud Valencia - Sleep Unit
  • Vitoria-Gasteiz, Spain, 01004
    • Hospital Universitario Araba
• Switzerland
  • Basel, Switzerland, 4031
    • Universitäts-Kinderspital beider Basel (UKBB)
  • Lugano, Switzerland, 6900
    • Ospedale Regionale di Lugano Civico - Neurocentro della Svizzera Italiana, Sleep Medicine Unit
• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Banner - University Medical Center Tucson
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Preferred Research Partners, Inc.
  • Florida
    • Brandon, Florida, United States, 33511
      • Teradan Clinical Trials
    • Miami, Florida, United States, 33155
      • D&H National Research Centers, Inc.
    • Miami, Florida, United States, 33166
      • Hope Research Network
    • Tampa, Florida, United States, 33606
      • University of South Florida - Tampa General Hospital (TGH)
    • Weston, Florida, United States, 33331
      • Encore Medical Research of Weston
    • Winter Park, Florida, United States, 32789
      • Florida Pediatric Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • NeuroTrials Research, Inc.
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Institute
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Bogan Sleep Consultants, LLC
  • Virginia
    • Richmond, Virginia, United States, 23294
      • National Clinical Research, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion 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.

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo will be taken orally, once daily in the evening during the treatment period.
Experimental: Daridorexant 25 mg	Drug: Daridorexant 25 mg; Daridorexant will be taken orally, once daily in the evening during the treatment period.
Experimental: Daridorexant 50 mg	Drug: Daridorexant 50 mg; Daridorexant will be taken orally, once daily in the evening during the treatment period.
Experimental: Daridorexant 10 mg	Drug: Daridorexant 10 mg; Daridorexant will be taken orally, once daily in the evening during the treatment period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to Day 1 in Total Sleep Time (TST) as measured by polysomnography (PSG).	Baseline is defined as the mean of the 2 PSG nights during the screening period.	PSG will be performed on 2 nights during the screening period and on Day 1 of the treatment period (total duration: 3 days).

Collaborators and Investigators

• Sponsor: Idorsia Pharmaceuticals Ltd.
• Investigators: Study Director: Clinical Trials, Idorsia Pharmaceuticals Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2022
• Primary Completion (Actual): January 12, 2026
• Study Completion (Actual): February 5, 2026

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders; Substandard Drugs; Pharmaceutical Preparations; daridorexant
• Other Study ID Numbers: ID-078A205; 2024-513885-20-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No