Daridorexant for Pediatric Insomnia
Recruiting in Palo Alto (17 mi)
+32 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Idorsia Pharmaceuticals Ltd.
Must be taking: CNS stimulants
Disqualifiers: Sleep apnea, Narcolepsy, Bipolar, others
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests the safety and effectiveness of a sleep medicine called daridorexant in children and teenagers who have trouble sleeping. The medicine helps them sleep better by blocking signals in the brain that keep them awake. Daridorexant has been studied in adults for its effectiveness in improving sleep onset and maintenance.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are using CNS stimulants (medications that affect the central nervous system), you can continue them if they were started at least 4 weeks before the trial and remain stable during the study.
What data supports the effectiveness of the drug Daridorexant for pediatric insomnia?
Daridorexant has been shown to be effective in improving sleep in adults with insomnia, as it helps reduce the drive to stay awake by blocking certain brain receptors. While specific data for pediatric insomnia is not available, its success in adults suggests potential benefits for children as well.
12345Is Daridorexant safe for humans?
Daridorexant has been generally well tolerated in clinical trials for insomnia, with common side effects like sleepiness, fatigue, and dizziness occurring at similar or slightly higher rates than with a placebo. Most side effects were mild, and no new safety concerns were found in a 12-month extension trial.
12346How is the drug Daridorexant unique for treating pediatric insomnia?
Daridorexant is unique because it is a dual orexin receptor antagonist, which means it works by blocking the signals that keep you awake, helping to reduce the wake drive and improve sleep. It is designed to have a duration of effect that minimizes next-day drowsiness, a common issue with other insomnia treatments.
12345Eligibility Criteria
This trial is for children and teenagers aged 10 to less than 18 years with chronic insomnia, which means they've had trouble sleeping for at least three months. They should have difficulty sleeping at least three nights a week despite good sleep opportunities. The study excludes those under 25 kg, who nap a lot during the day, or have other sleep disorders or significant medical conditions.Inclusion Criteria
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
I have had trouble sleeping for over 3 months, affecting my daily life.
I am between 10 and 17 years old.
+2 more
Exclusion Criteria
I have been diagnosed with a sleep disorder like restless legs or narcolepsy.
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
I have a history of sleep-related breathing disorders, but I'm still eligible if treated by tonsillectomy/adenoidectomy.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
2 visits (in-person)
Treatment
Participants receive multiple-dose oral administration of daridorexant or placebo
3 days
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The trial is testing different doses of Daridorexant (10 mg, 25 mg, and 50 mg) against a placebo to see how well it works and its safety in young people with insomnia. Participants will take the medication orally over multiple doses to assess its effects on their sleep issues.
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Daridorexant 50 mgExperimental Treatment1 Intervention
Group II: Daridorexant 25 mgExperimental Treatment1 Intervention
Group III: Daridorexant 10 mgExperimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention
Daridorexant is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Quviviq for:
- Insomnia
🇪🇺 Approved in European Union as Quviviq for:
- Insomnia
🇨🇦 Approved in Canada as Quviviq for:
- Insomnia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Western Michigan Homer Stryker M.D. School of Medicine (WMed)Kalamazoo, MI
Florida Pediatric Research InstituteWinter Park, FL
Hope Research NetworkMiami, FL
University of South Florida - Tampa General Hospital (TGH)Tampa, FL
More Trial Locations
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Who Is Running the Clinical Trial?
Idorsia Pharmaceuticals Ltd.Lead Sponsor
References
Daridorexant: First Approval. [2022]Daridorexant (Quviviq™; Idorsia Pharmaceuticals Ltd.) is an orally administered dual orexin type 1 and type 2 (OX1 and OX2) receptor antagonist (DORA) being developed for the treatment of insomnia. It was selected from a pool of drug candidates on the basis of an expected effect duration of ≈ 8 h at a dose of 25 mg, with a half-life intended to minimize residual effects that might impair daytime functioning. Based on the results of two pivotal phase III trials, daridorexant was recently approved in the USA for the treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance. This article summarizes the milestones in the development of daridorexant leading to this first approval.
Daridorexant in Insomnia Disorder: A Profile of Its Use. [2023]Daridorexant (Quviviq™) is a useful option for the treatment of insomnia disorder, which has shown efficacy in younger and older adults. It antagonises the orexin receptors, thereby reducing the wake drive. Daridorexant is the first dual orexin receptor antagonist to be approved for the treatment of chronic insomnia in the EU and has been approved for insomnia in the USA. In phase 3 clinical trials, daridorexant dose-dependently improved objective latency to persistent sleep, objective wake time after sleep onset, subjective total sleep time and, at the 50 mg dose, subjective daytime functioning compared with placebo. Daridorexant was generally well tolerated. Adverse events (AEs) commonly associated with insomnia drugs, such as somnolence, fatigue and dizziness, occurred at a similar or slightly greater frequency with daridorexant than with placebo. Falls occurred at a similar or lower frequency with daridorexant than with placebo. Most AEs were mild in severity and the incidence was not dose-dependent. The efficacy of daridorexant was maintained during a 12-month extension trial, with no new safety or tolerability concerns.
Daridorexant: Comprehensive Review of A New Oral Agent for the Treatment of Insomnia. [2023]To review the current pharmacology, pharmacokinetics/pharmacodynamics, safety, and efficacy of daridorexant in patients with insomnia.
Daridorexant: A New Dual Orexin Receptor Antagonist for Insomnia. [2023]Objective: To review the safety, efficacy, and tolerability of daridorexant in treating insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adult patients. Data Sources: A literature search was performed through PubMed using the following key terms: daridorexant, ACT-541468, orexin, insomnia, and sleep. Study Selection and Data Extraction: Selected articles included those which described clinical studies of the pharmacokinetics, efficacy, safety, or tolerability of daridorexant. Data Synthesis: Daridorexant works through antagonism of the dual orexin receptor. It is the third agent in this class of medications approved by the U.S. Food and Drug Administration (FDA). Daridorexant, at a dose of 25 mg to 50 mg, was shown to be effective in improving sleep parameters in phase 3 clinical studies and was well tolerated. Adverse event rates from phase 2 and 3 clinical trials were low with fatigue, nasopharyngitis, gait disturbance, somnolence, diarrhea, and headache most commonly reported. Conclusions: All currently available agents for treating insomnia have received a "weak" recommendation in the clinical practice guidelines, including the dual orexin receptor antagonist class of medications. Initial data suggest that with routine use daridorexant does not impair next day functioning, a common issue with other agents used to treat insomnia. In addition, daridorexant appears to be as safe and effective in treating insomnia in patients of all ages including those ≥65 years of age.
Effect of gastric pH and of a moderate CYP3A4 inducer on the pharmacokinetics of daridorexant, a dual orexin receptor antagonist. [2022]Daridorexant is a dual orexin receptor antagonist developed for the treatment of insomnia. The solubility of daridorexant is pH-dependent and daridorexant has been shown to be a sensitive CYP3A4 substrate when co-administered with moderate CYP3A4 inhibitors. The purpose of this study was to assess the effect of an increased gastric pH on daridorexant pharmacokinetics (PK) and the extent of interaction when daridorexant is co-administered with a moderate CYP3A4 inducer.
Impact of Daridorexant, a Dual Orexin Receptor Antagonist, on Cardiac Repolarization Following Bedtime Dosing: Results from a Thorough QT Study Using Concentration-QT Analysis. [2021]Daridorexant is a new dual orexin receptor antagonist currently in late-stage clinical development for the treatment of insomnia. This randomized, double-blind, placebo-controlled, four-period crossover study investigated the effect of daridorexant at a therapeutic and supratherapeutic dose on QT interval duration.