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

NCT05423717 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: ID-078A2052024-513885-20-00
• Study Type: interventional
• Target: 166
• Locations: 6 countries
• Sites: 35

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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (4)

Daridorexant 10 mg

EXPERIMENTAL

Drug: Daridorexant 10 mg

Daridorexant 25 mg

EXPERIMENTAL

Drug: Daridorexant 25 mg

Daridorexant 50 mg

EXPERIMENTAL

Drug: Daridorexant 50 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Daridorexant 10 mg DRUG

Daridorexant will be taken orally, once daily in the evening during the treatment period.

Daridorexant 10 mg

Daridorexant 25 mg DRUG

Daridorexant will be taken orally, once daily in the evening during the treatment period.

Daridorexant 25 mg

Daridorexant 50 mg DRUG

Daridorexant will be taken orally, once daily in the evening during the treatment period.

Daridorexant 50 mg

Placebo DRUG

Placebo will be taken orally, once daily in the evening during the treatment period.

Placebo

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (35)

Banner - University Medical Center Tucson

Tucson, Arizona, 85724, United States

Location

Preferred Research Partners, Inc.

Little Rock, Arkansas, 72211, United States

Location

Teradan Clinical Trials

Brandon, Florida, 33511, United States

Location

D&H National Research Centers, Inc.

Miami, Florida, 33155, United States

Location

Hope Research Network

Miami, Florida, 33166, United States

Location

University of South Florida - Tampa General Hospital (TGH)

Tampa, Florida, 33606, United States

Location

Encore Medical Research of Weston

Weston, Florida, 33331, United States

Location

Florida Pediatric Research Institute

Winter Park, Florida, 32789, United States

Location

NeuroTrials Research, Inc.

Atlanta, Georgia, 30328, United States

Location

Clinical Research Institute

Stockbridge, Georgia, 30281, United States

Location

Bogan Sleep Consultants, LLC

Columbia, South Carolina, 29201, United States

Location

National Clinical Research, Inc

Richmond, Virginia, 23294, United States

Location

MC Zdrave 1 Ltd.

Kozloduy, 3320, Bulgaria

Location

MHAT "Heart and Brain" (SJSC)

Pleven, 508, Bulgaria

Location

University Hospital (UMHAT) Sveti Georgi

Plovdiv, 4001, Bulgaria

Location

MC ReSpiro Ltd.

Razgrad, 7200, Bulgaria

Location

MC Sun I Zdrave ("Sleep and health") Ltd.

Sofia, 1618, Bulgaria

Location

MC Kalimat

Sofia, 1680, Bulgaria

Location

MC Inspiro

Sofia, 1784, Bulgaria

Location

MC Sanamedik Ltd.

Varna, 9000, Bulgaria

Location

Advanced Sleep Research Berlin GmbH

Berlin, 10117, Germany

Location

Charité -Universitätsmedizin Berlin

Berlin, 12203, Germany

Location

Vestische Caritas-Kliniken GmbH, Vestische Kinder- und Jugendklinik Datteln

Datteln, 45711, Germany

Location

ProSomno

München, 80333, Germany

Location

SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH

Schwerin, 19053, Germany

Location

IRCCS Ospedale Bellaria

Bologna, 40139, Italy

Location

Meyer Children's Hospital

Florence, 50139, Italy

Location

Institute Giannina Gaslini

Genova, 16147, Italy

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital de La Santa Creu I Sant Pau

Barcelona, 08041, Spain

Location

HM Puerta del Sur, Unidad del Sueño

Móstoles, 28938, Spain

Location

Hospital Quironsalud Valencia - Sleep Unit

Valencia, 46010, Spain

Location

Hospital Universitario Araba

Vitoria-Gasteiz, 01004, Spain

Location

Universitäts-Kinderspital beider Basel (UKBB)

Basel, 4031, Switzerland

Location

Ospedale Regionale di Lugano Civico - Neurocentro della Svizzera Italiana, Sleep Medicine Unit

Lugano, 6900, Switzerland

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

daridorexant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Clinical Trials

  Idorsia Pharmaceuticals Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 21, 2022
• Study Start: September 6, 2022
• Primary Completion: January 12, 2026
• Study Completion: February 5, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3); ES (5); DE (5); BU (8); CH (2); US (12)