drugset / Trial / NCT05546554

Trial of Suvorexant for Sleep in Children With Autism

NCT05546554

RandomizedCrossoverQuadruple-blindBasic science

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.

Timeline

Start
2023-08-09
Primary completion
2028-02-28
Completion
2028-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Suvorexant Small molecule Oral

Indications