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

Sponsor

Idorsia Pharmaceuticals Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05423717

Collaborator

(none)

150

Enrollment

Locations

Arms

12.3

Anticipated Duration (Months)

12.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Insomnia	Drug: Daridorexant 10 mg Drug: Daridorexant 25 mg Drug: Daridorexant 50 mg Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Aug 9, 2022

Anticipated Primary Completion Date :

Jul 29, 2023

Anticipated Study Completion Date :

Aug 19, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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 (SDSC) score > 16 on the Difficulty Initiating or Maintaining Sleep domain at Screening.
Adolescent of Child-Bearing Potential (AoCBP):

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.
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:

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.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Preferred Research Partners, Inc.	Little Rock	Arkansas	United States	72211
2	Children's Hospital Los Angeles	Los Angeles	California	United States	90027
3	Pacific Clinical Research Management Group LLC	Upland	California	United States	91786
4	Teradan Clinical Trials	Brandon	Florida	United States	33511
5	D&H National Research Centers, Inc.	Miami	Florida	United States	33155
6	Florida Pediatric Research Institute	Winter Park	Florida	United States	32789
7	NeuroTrials Research, Inc.	Atlanta	Georgia	United States	30328
8	Clinical Research Institute	Stockbridge	Georgia	United States	30281
9	Western Michigan Homer Stryker M.D. School of Medicine	Kalamazoo	Michigan	United States	49008
10	OnSite Clinical Solutions, LLC	Charlotte	North Carolina	United States	28277
11	Bogan Sleep Consultants, LLC	Columbia	South Carolina	United States	29201
12	National Clinical Research, Inc	Richmond	Virginia	United States	23294

Sponsors and Collaborators

Idorsia Pharmaceuticals Ltd.

Investigators

Study Director: Clinical Trials, Idorsia Pharmaceuticals Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Idorsia Pharmaceuticals Ltd.

ClinicalTrials.gov Identifier:

NCT05423717

Other Study ID Numbers:

ID-078A205

First Posted:

Jun 21, 2022

Last Update Posted:

Aug 16, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Aug 16, 2022