- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05423717
Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder
March 18, 2024 updated by: Idorsia Pharmaceuticals Ltd.
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
150
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Idorsia Clinical Trials Information
- Phone Number: +1 856 66 13 721
- Email: idorsiaclinicaltrials@idorsia.com
Study Locations
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Edegem, Belgium, 2650
- Withdrawn
- University Hospital Antwerp (Department Pediatrics)
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Gent, Belgium, 9000
- Withdrawn
- University Hospital Gent, Pediatric Sleep Center
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Kozloduy, Bulgaria, 3320
- Not yet recruiting
- MC Zdrave 1 Ltd.
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Plovdiv, Bulgaria, 4001
- Not yet recruiting
- University Hospital (UMHAT) Sveti Georgi
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Razgrad, Bulgaria, 7200
- Not yet recruiting
- MC ReSpiro Ltd.
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Sofia, Bulgaria, 1408
- Not yet recruiting
- MC Avitsena Ltd.
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Sofia, Bulgaria, 1680
- Not yet recruiting
- MC Kalimat
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Sofia, Bulgaria, 1784
- Not yet recruiting
- MC Inspiro
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Varna, Bulgaria, 9000
- Not yet recruiting
- MC Sanamedik Ltd.
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Berlin, Germany, 10117
- Recruiting
- Advanced Sleep Research Berlin GmbH
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Schwerin, Germany, 19053
- Recruiting
- SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
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Barcelona, Spain, 08035
- Recruiting
- Hospital Universitari Vall d'Hebron
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Barcelona, Spain, 08017
- Recruiting
- Centro Médico Teknon - Medicina del Sueño
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Barcelona, Spain, 08950
- Withdrawn
- Hospital Sant Joan de Deu
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Madrid, Spain, 28046
- Recruiting
- Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz
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Móstoles, Spain, 28938
- Recruiting
- HM Puerta del Sur, Unidad del Sueño
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Valencia, Spain, 46010
- Recruiting
- Hospital Quironsalud Valencia - Sleep Unit
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Vitoria-Gasteiz, Spain, 01004
- Recruiting
- Hospital Universitario Araba
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Arizona
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Tucson, Arizona, United States, 85724
- Recruiting
- Banner - University Medical Center Tucson
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Arkansas
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Little Rock, Arkansas, United States, 72211
- Recruiting
- Preferred Research Partners, Inc.
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California
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Los Angeles, California, United States, 90027
- Withdrawn
- Children's Hospital Los Angeles
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Upland, California, United States, 91786
- Withdrawn
- Pacific Clinical Research Management Group LLC
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Florida
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Brandon, Florida, United States, 33511
- Recruiting
- Teradan Clinical Trials
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Miami, Florida, United States, 33155
- Completed
- D&H National Research Centers, Inc.
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Winter Park, Florida, United States, 32789
- Recruiting
- Florida Pediatric Research Institute
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Georgia
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Atlanta, Georgia, United States, 30328
- Completed
- Neurotrials Research, Inc.
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Decatur, Georgia, United States, 30030
- Withdrawn
- CenExel iResearch, LLC
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Stockbridge, Georgia, United States, 30281
- Completed
- Clinical Research Institute
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Michigan
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Kalamazoo, Michigan, United States, 49008
- Withdrawn
- Western Michigan Homer Stryker M.D. School of Medicine
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North Carolina
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Charlotte, North Carolina, United States, 28277
- Withdrawn
- OnSite Clinical Solutions, LLC
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Ohio
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Cleveland, Ohio, United States, 44106
- Withdrawn
- Rainbow Babies and Children's Hospital of University Hospitals
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South Carolina
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Columbia, South Carolina, United States, 29201
- Recruiting
- Bogan Sleep Consultants, LLC
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Virginia
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Richmond, Virginia, United States, 23294
- Completed
- National Clinical Research, Inc
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 17 years (Child)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo will be taken orally, once daily in the evening during the treatment period.
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Experimental: Daridorexant 25 mg
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Daridorexant will be taken orally, once daily in the evening during the treatment period.
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Experimental: Daridorexant 50 mg
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Daridorexant will be taken orally, once daily in the evening during the treatment period.
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Experimental: Daridorexant 10 mg
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Daridorexant will be taken orally, once daily in the evening during the treatment period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline to Day 1 in Total Sleep Time (TST) as measured by polysomnography (PSG).
Time Frame: PSG will be performed on 2 nights during the screening period and on Day 1 of the treatment period (total duration: 3 days).
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Baseline is defined as the mean of the 2 PSG nights during the screening period.
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PSG will be performed on 2 nights during the screening period and on Day 1 of the treatment period (total duration: 3 days).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Trials, Idorsia Pharmaceuticals Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 9, 2022
Primary Completion (Estimated)
March 23, 2025
Study Completion (Estimated)
April 27, 2025
Study Registration Dates
First Submitted
June 14, 2022
First Submitted That Met QC Criteria
June 14, 2022
First Posted (Actual)
June 21, 2022
Study Record Updates
Last Update Posted (Actual)
March 19, 2024
Last Update Submitted That Met QC Criteria
March 18, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ID-078A205
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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