Insomnia Disorder
Conditions
Sponsors
Idorsia Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria applicable to all subjects: - 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 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. Are the trial subjects under 18? yes Number of subjects for this age range: 150 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the dose-response relationship of daridorexant on objective total sleep time (TST) using polysomnography (PSG) in pediatric subjects with insomnia disorder.;Secondary Objective: To assess the safety and tolerability of daridorexant in pediatric subjects with insomnia disorder.;Primary end point(s): Change from baseline to Day 1 in TST (in min) as measured by polysomnography (PSG).;Timepoint(s) of evaluation of this end point: 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable. | — |
Countries
Belgium, Bulgaria, Germany, Spain
Contacts
Public ContactClinical Trial Disclosure Desk
Idorsia Pharmaceuticals Ltd
Outcome results
None listed