Trial of Suvorexant for Sleep in Children With Autism

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT05546554
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
13 Years - 17 Years
Healthy Volunteers
Accepted

Interventions

  • Suvorexant — DRUG
    5 mg (and up to 20 mg) Suvorexant given orally
  • Placebo — DRUG
    Matching Placebo given orally

Study Details

The purpose of this study is to examine the effect of suvorexant on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Suvorexant is a selective, dual orexin receptor antagonist (DORA) used for the treatment of sleep onset difficulties and/or sleep maintenance. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of suvorexant on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.

Key Dates

Start date
Aug 9, 2023
Status verified
Mar 2026
Primary completion
Feb 28, 2028
Completion
Feb 28, 2028

Study Design

Enrollment
26 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Suvorexant, then Placebo
    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.
  • Experimental: Placebo, then Suvorexant
    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.

Primary Outcome Measure

Change from baseline in sleep architecture as measured by polysomnography (PSG) and/or actigraphy, examples include sleep latency and non-rapid eye movement (NREM) [ Time Frame: Baseline, Week 4 and Week 8 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305-5719
Ryan Villacrucis
[email protected]
(650) 736-1235
Robin Libove
[email protected]
(650) 736-1235
Antonio Y. Hardan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Stanford, CA

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Stanford University· Stanford, CA

Related Studies