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Dual Orexin Receptor Antagonist

Suvorexant for Sleep Issues in Children with Autism

Phase 2
Recruiting
Led By Antonio Y. Hardan, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is testing suvorexant, a sleep aid, in children and adolescents with Autism Spectrum Disorder who have sleep problems. Suvorexant helps people fall asleep and stay asleep by blocking wakefulness signals in the brain.

Who is the study for?
This trial is for children aged 13-17 with Autism Spectrum Disorder who have sleep issues, confirmed by clinical evaluation and specific tests. They must be on stable medications, willing to undergo sleep studies, and not planning any treatment changes during the study. Sexually active females must use dual contraception.
What is being tested?
The trial is testing Suvorexant's effects on sleep in autistic children compared to a placebo. It's an 8-week study where participants are randomly assigned to receive either the drug or placebo first, then switch halfway without knowing which one they're taking.
What are the potential side effects?
Suvorexant may cause side effects like daytime drowsiness, headaches, dizziness, dry mouth, coughing or wheezing; it can also potentially worsen depression or suicidal thoughts in those at risk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Group I: Suvorexant, then PlaceboExperimental Treatment2 Interventions
Participants will first receive Suvorexant for a 4-week period. A starting dose will be 5 mg at bedtime and can be increased by 5 mg only if needed and if well tolerated on a weekly basis until the maximum dose of 20 mg/day is reached. Participants will be maintained on the lowest effective dose. Participants will then receive Placebo (fake tablet) for a 4-week period. A starting dose will be 5 mg at bedtime and can be increased by 5 mg only if needed and if well tolerated on a weekly basis until the maximum dose of 20 mg/day is reached. Participants will be maintained on the lowest effective dose.
Group II: Placebo, then SuvorexantExperimental Treatment2 Interventions
Participants will first receive Placebo (fake tablet) for a 4-week period. A starting dose will be 5 mg at bedtime and can be increased by 5 mg only if needed and if well tolerated on a weekly basis until the maximum dose of 20 mg/day is reached. Participants will be maintained on the lowest effective dose. Participants will then receive Suvorexant for a 4-week period. A starting dose will be 5 mg at bedtime and can be increased by 5 mg only if needed and if well tolerated on a weekly basis until the maximum dose of 20 mg/day is reached. Participants will be maintained on the lowest effective dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Suvorexant
2016
Completed Phase 4
~2200

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Autism Spectrum Disorder (ASD) often target sleep disturbances, a prevalent issue in ASD patients. Suvorexant, a Dual Orexin Receptor Antagonist (DORA), works by inhibiting the action of orexin, a neurotransmitter that regulates wakefulness, thereby promoting sleep onset and maintenance. Melatonin, a hormone that regulates the sleep-wake cycle, is another common treatment that helps improve sleep quality in ASD patients. Clonidine, an alpha-2 adrenergic agonist, is also used to address sleep issues by reducing hyperarousal. These treatments are significant for ASD patients as they help manage sleep disturbances, which can exacerbate other ASD symptoms and negatively impact overall functioning and quality of life.
Evaluation of drug interventions for the treatment of sleep disorders in children with autism spectrum disorders: a systematic review.[Psychopharmacology of autistic disorders].

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,453 Previous Clinical Trials
17,494,257 Total Patients Enrolled
35 Trials studying Autism Spectrum Disorder
3,786 Patients Enrolled for Autism Spectrum Disorder
National Institutes of Health (NIH)NIH
2,769 Previous Clinical Trials
8,134,963 Total Patients Enrolled
21 Trials studying Autism Spectrum Disorder
2,470 Patients Enrolled for Autism Spectrum Disorder
Antonio Y. Hardan, MDPrincipal InvestigatorStanford University
9 Previous Clinical Trials
455 Total Patients Enrolled
8 Trials studying Autism Spectrum Disorder
407 Patients Enrolled for Autism Spectrum Disorder

Media Library

Suvorexant (Dual Orexin Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05546554 — Phase 2
Autism Spectrum Disorder Research Study Groups: Suvorexant, then Placebo, Placebo, then Suvorexant
Autism Spectrum Disorder Clinical Trial 2023: Suvorexant Highlights & Side Effects. Trial Name: NCT05546554 — Phase 2
Suvorexant (Dual Orexin Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05546554 — Phase 2
~17 spots leftby Feb 2027
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