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

Insomnia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05423717
• Other study ID #: ID-078A205
• Status: Recruiting
• Phase: Phase 2
• Start date: August 9, 2022
• Est. completion date: April 27, 2025

Study information

• Verified date: June 2024
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: Idorsia Clinical Trials Information
• Phone: +1 856 66 13 721
• Email: idorsiaclinicaltrials[@]idorsia.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 27, 2025
• Est. primary completion date: March 23, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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 (IRBs) / independent ethics committees (IECs).
• 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 (ICSD), 3rd edition or insomnia disorder in accordance with 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 (SDSC) score > 16 on the Difficulty Initiating or Maintaining Sleep domain at Screening.
• Adolescent of Child-Bearing Potential (AoCBP):

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: Must have a documented history of NDD (including ASD or ADHD) according to DSM-5 criteria, as confirmed by review of medical records, at Screening. Use of CNS stimulants is allowed if started at least 4 weeks prior to Screening, stable and expected to remain stable during the study until EOT. 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 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, ECG 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 (CBT) 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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Daridorexant 10 mg
Daridorexant will be taken orally, once daily in the evening during the treatment period.
• Daridorexant 25 mg
Daridorexant will be taken orally, once daily in the evening during the treatment period.
• Daridorexant 50 mg
Daridorexant will be taken orally, once daily in the evening during the treatment period.
• Placebo
Placebo will be taken orally, once daily in the evening during the treatment period.

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp (Department Pediatrics)	Edegem
Belgium	University Hospital Gent, Pediatric Sleep Center	Gent
Bulgaria	MC Zdrave 1 Ltd.	Kozloduy
Bulgaria	University Hospital (UMHAT) Sveti Georgi	Plovdiv
Bulgaria	MC ReSpiro Ltd.	Razgrad
Bulgaria	MC Avitsena Ltd.	Sofia
Bulgaria	MC Inspiro	Sofia
Bulgaria	MC Kalimat	Sofia
Bulgaria	MC Sanamedik Ltd.	Varna
Germany	Advanced Sleep Research Berlin GmbH	Berlin
Germany	Vestische Caritas-Kliniken GmbH, Vestische Kinder- und Jugendklinik Datteln	Datteln
Germany	SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH	Schwerin
Italy	S.C. Neuropsichiatria Infantile	Bari
Italy	IRCCS Ospedale Bellaria	Bologna
Italy	Meyer Children's Hospital	Florence
Italy	Institute Giannina Gaslini	Genova
Italy	Ospedale San Paolo	Milano
Italy	Centro di Medicina del Sonno	Monserrato
Italy	Sapienza University	Roma
Spain	Centro Médico Teknon - Medicina del Sueño	Barcelona
Spain	Hospital Sant Joan de Deu	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz	Madrid
Spain	HM Puerta del Sur, Unidad del Sueño	Móstoles
Spain	Hospital Quironsalud Valencia - Sleep Unit	Valencia
Spain	Hospital Universitario Araba	Vitoria-Gasteiz
United States	NeuroTrials Research, Inc.	Atlanta	Georgia
United States	Teradan Clinical Trials	Brandon	Florida
United States	OnSite Clinical Solutions, LLC	Charlotte	North Carolina
United States	Rainbow Babies and Children's Hospital of University Hospitals	Cleveland	Ohio
United States	Bogan Sleep Consultants, LLC	Columbia	South Carolina
United States	CenExel iResearch, LLC	Decatur	Georgia
United States	Western Michigan Homer Stryker M.D. School of Medicine	Kalamazoo	Michigan
United States	Preferred Research Partners, Inc.	Little Rock	Arkansas
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	D&H National Research Centers, Inc.	Miami	Florida
United States	National Clinical Research, Inc	Richmond	Virginia
United States	Clinical Research Institute	Stockbridge	Georgia
United States	Banner - University Medical Center Tucson	Tucson	Arizona
United States	Pacific Clinical Research Management Group LLC	Upland	California
United States	Florida Pediatric Research Institute	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Germany,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).