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

NCT ID: NCT05423717

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-06
• Study Completion Date: 2026-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Daridorexant 10 mg

Group Type: EXPERIMENTAL

Daridorexant 10 mg

Intervention Type: DRUG

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

Daridorexant 25 mg

Group Type: EXPERIMENTAL

Daridorexant 25 mg

Intervention Type: DRUG

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

Daridorexant 50 mg

Group Type: EXPERIMENTAL

Daridorexant 50 mg

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Daridorexant 10 mg

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

Intervention Type: DRUG

Daridorexant 25 mg

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

Intervention Type: DRUG

Daridorexant 50 mg

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Idorsia Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Idorsia Pharmaceuticals Ltd.

Locations

Banner - University Medical Center Tucson

Tucson, Arizona, United States

Preferred Research Partners, Inc.

Little Rock, Arkansas, United States

Teradan Clinical Trials

Brandon, Florida, United States

D&H National Research Centers, Inc.

Miami, Florida, United States

Hope Research Network

Miami, Florida, United States

University of South Florida - Tampa General Hospital (TGH)

Tampa, Florida, United States

Encore Medical Research of Weston

Weston, Florida, United States

Florida Pediatric Research Institute

Winter Park, Florida, United States

NeuroTrials Research, Inc.

Atlanta, Georgia, United States

Clinical Research Institute

Stockbridge, Georgia, United States

Bogan Sleep Consultants, LLC

Columbia, South Carolina, United States

National Clinical Research, Inc

Richmond, Virginia, United States

MC Zdrave 1 Ltd.

Kozloduy, , Bulgaria

MHAT "Heart and Brain" (SJSC)

Pleven, , Bulgaria

University Hospital (UMHAT) Sveti Georgi

Plovdiv, , Bulgaria

MC ReSpiro Ltd.

Razgrad, , Bulgaria

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

Sofia, , Bulgaria

MC Kalimat

Sofia, , Bulgaria

MC Inspiro

Sofia, , Bulgaria

MC Sanamedik Ltd.

Varna, , Bulgaria

Advanced Sleep Research Berlin GmbH

Berlin, , Germany

Charité -Universitätsmedizin Berlin

Berlin, , Germany

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

Datteln, , Germany

ProSomno

München, , Germany

SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH

Schwerin, , Germany

IRCCS Ospedale Bellaria

Bologna, , Italy

Meyer Children's Hospital

Florence, , Italy

Institute Giannina Gaslini

Genova, , Italy

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Hospital de La Santa Creu I Sant Pau

Barcelona, , Spain

HM Puerta del Sur, Unidad del Sueño

Móstoles, , Spain

Hospital Quironsalud Valencia - Sleep Unit

Valencia, , Spain

Hospital Universitario Araba

Vitoria-Gasteiz, , Spain

Universitäts-Kinderspital beider Basel (UKBB)

Basel, , Switzerland

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

Lugano, , Switzerland

Countries

United States; Bulgaria; Germany; Italy; Spain; Switzerland

Other Identifiers

2024-513885-20-00

Identifier Type: CTIS

Identifier Source: secondary_id

ID-078A205

Identifier Type: -

Identifier Source: org_study_id