Trial of Suvorexant for Sleep in Children With Autism
Recruiting
Phase 2
Interventional Study
Autism
Autism Spectrum Disorder
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 13 – 17
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Basic Science
- Participants needed
- 26 (estimated)
- Sponsor
- Stanford University · Other
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About This Trial
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 des…
Trial Locations
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Eligibility Criteria
Inclusion criteria:
Participants will meet the following
* Outpatients between 13 and 17 years of age at time of consent
* Diagnostic and Statistical Manual, 5th edition (DSM-5) criteria for Autism Spectrum Disorder (ASD) on the basis of clinical evaluation, confirmed with the Autism Diagnostic In…
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