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NCT05546554 · ClinicalTrials.gov registry record · Phase 2
Trial of Suvorexant for Sleep in Children With Autism
A Phase 2 study of Autism Spectrum Disorder and Autism, sponsored by Stanford University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT05546554: Recruiting Phase 2 study of Autism Spectrum Disorder and Autism, sponsored by Stanford University.
NCT05546554 is a Phase 2 study of Autism Spectrum Disorder and Autism that is actively recruiting participants, run by Stanford University. The registered enrollment target is 26 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05546554, a Phase 2 study of Autism Spectrum Disorder and Autism, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Suvorexant
Study Locations (1)
California
- Stanford University - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2023-08-09 |
| Est. Completion | 2028-02-28 |
| Phase | Phase 2 |
What NCT05546554 shows while recruiting
NCT05546554 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (81% lower).
The record links to 2 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05546554 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05546554 about?
NCT05546554 is a clinical study titled "Trial of Suvorexant for Sleep in Children With Autism". 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...
What is the current status of trial NCT05546554?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2023-08-09. Estimated completion is 2028-02-28.
What conditions does trial NCT05546554 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Autism.
What interventions are being tested in trial NCT05546554?
The interventions under investigation include: Placebo (DRUG), Suvorexant (DRUG).
Who is sponsoring clinical trial NCT05546554?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05546554 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autism Spectrum Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05546554's enrollment target sits among peer trials
26 178th of 224 higher than 43 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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