A clinical study to investigate the safe and effective dose of Daridorexant for the treatment of sleep disorders in children and adolescents aged 10 to < 18 years

Belgium, Bulgaria, Germany, Italy, Spain, Switzerland, United States (ICTRP)

Identifiant de l'essai ICTRP
NCT05423717 (ICTRP)

Titre officiel (approuvé par le comité d'éthique)
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 (BASEC)

Titre académique
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 (ICTRP)

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

Maladie en cours d'investigation
Insomnia (ICTRP)

Intervention étudiée
Drug: Daridorexant 10 mgDrug: Daridorexant 25 mgDrug: Daridorexant 50 mgDrug: Placebo (ICTRP)

Type d'essai
Interventional (ICTRP)

Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)

Critères d'inclusion/exclusion
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. (ICTRP)

non disponible

Critères d'évaluation principaux et secondaires
Change from baseline to Day 1 in Total Sleep Time (TST) as measured by polysomnography (PSG). (ICTRP)

non disponible

Date d'enregistrement
non disponible

Inclusion du premier participant
non disponible

Sponsors secondaires
non disponible

Contacts supplémentaires
Clinical Trials;Idorsia Clinical Trials Information, idorsiaclinicaltrials@idorsia.com, +1 856 66 13 721, Idorsia Pharmaceuticals Ltd., (ICTRP)

ID secondaires
2024-513885-20-00, ID-078A205 (ICTRP)

Résultats-Données individuelles des participants
non disponible

Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT05423717 (ICTRP)