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RECRUITING
NCT05546554
PHASE2

Trial of Suvorexant for Sleep in Children With Autism

Sponsor: Stanford University

View on ClinicalTrials.gov

Summary

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.

Official title: Randomized Placebo-Controlled Crossover Trial of Suvorexant for Sleep in Children With Autism

Key Details

Gender

All

Age Range

13 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

26

Start Date

2023-08-09

Completion Date

2028-02-28

Last Updated

2026-03-27

Healthy Volunteers

Yes

Interventions

DRUG

Suvorexant

5 mg (and up to 20 mg) Suvorexant given orally

DRUG

Placebo

Matching Placebo given orally

Locations (1)

Stanford University

Stanford, California, United States