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Dual Orexin Receptor Antagonist

Suvorexant for Sleep Issues in Children with Autism

Phase 2

Recruiting

Led By Antonio Y. Hardan, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 4 and week 8

Awards & highlights

Study Summary

This trial will examine the effects of suvorexant on sleep in children and teens with ASD, using polysomnography, actigraphy, circadian rhythm, and clinical measures.

Who is the study for?

This trial is for children aged 13-17 with Autism Spectrum Disorder who have sleep issues, confirmed by clinical evaluation and specific tests. They must be on stable medications, willing to undergo sleep studies, and not planning any treatment changes during the study. Sexually active females must use dual contraception.Check my eligibility

What is being tested?

The trial is testing Suvorexant's effects on sleep in autistic children compared to a placebo. It's an 8-week study where participants are randomly assigned to receive either the drug or placebo first, then switch halfway without knowing which one they're taking.See study design

What are the potential side effects?

Suvorexant may cause side effects like daytime drowsiness, headaches, dizziness, dry mouth, coughing or wheezing; it can also potentially worsen depression or suicidal thoughts in those at risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 4 and week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 4 and week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4 and week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Polysomnography

Secondary outcome measures

Change from baseline in sleep efficiency as measured by actigraphy

Other outcome measures

Change from baseline on Aberrant Behavior Checklist, Second Edition (ABC-2) subscale scores

Change from baseline on Child Behavior Checklist (CBCL) scores

Change from baseline on Children's Sleep Habits Questionnaire (CSHQ) subscale scores

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Suvorexant, then PlaceboExperimental Treatment2 Interventions

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.

Group II: Placebo, then SuvorexantExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Suvorexant

2016

Completed Phase 4

~2120

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,398 Previous Clinical Trials

17,342,074 Total Patients Enrolled

33 Trials studying Autism Spectrum Disorder

4,071 Patients Enrolled for Autism Spectrum Disorder

National Institutes of Health (NIH)NIH

2,706 Previous Clinical Trials

7,507,887 Total Patients Enrolled

20 Trials studying Autism Spectrum Disorder

2,420 Patients Enrolled for Autism Spectrum Disorder

Antonio Y. Hardan, MDPrincipal InvestigatorStanford University

8 Previous Clinical Trials

425 Total Patients Enrolled

7 Trials studying Autism Spectrum Disorder

377 Patients Enrolled for Autism Spectrum Disorder

Media Library

Suvorexant (Dual Orexin Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05546554 — Phase 2

Autism Spectrum Disorder Research Study Groups: Suvorexant, then Placebo, Placebo, then Suvorexant

Autism Spectrum Disorder Clinical Trial 2023: Suvorexant Highlights & Side Effects. Trial Name: NCT05546554 — Phase 2

Suvorexant (Dual Orexin Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05546554 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there risks associated with the administration of Suvorexant?

"Suvorexant's safety has been supported by some data, hence the rating of 2. There is no existing evidence of efficacy for this drug yet as it is a Phase 2 trial."

Answered by AI

Are there any openings in this experiment for new participants?

"Affirmative. Clinicaltrials.gov contains information that confirms this medical exploration is actively in search of participants, having been posted on July 12th 2023 and updated most recently on the following day. The analysis necessitates 26 individuals from a single clinical trial site."

Answered by AI

Are individuals aged forty and above eligible for participation in this experiment?

"Per the conditions for entry into this trial, adolescent participants must be no younger than 13 years old and not beyond their 17th birthday."

Answered by AI

What criteria must a person meet to be eligible for participation in this experiment?

"This clinical trial is aiming to recruit 26 individuals aged 13-17 with Autism Spectrum Disorder. To be eligible, participants must meet the following conditions: have a DSM-5 diagnosis of ASD that is confirmed by ADI-R and ADOS-2 tests; provide polysomnography (PSG) and actigraphy data; score higher than 41 on the CSHQ questionnaire and possess sleep efficiency below 80%; maintain stable medication for 4 weeks before enrolment; should not experience any changes in psychosocial or biomedical interventions during the period of study; donate extra saliva samples if required as well as participate in PSG, actigraph"

Answered by AI

How many participants are currently recruited for this scientific investigation?

"Affirmative. Clinicaltrials.gov records attest that the trial is actively recruiting, having been published on July 12th 2023 and most recently amended a day later. 26 individuals are sought from 1 medical centre for this experiment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial of Suvorexant for Sleep in Children With Autism

Antonio Hardan 2023. "Trial of Suvorexant for Sleep in Children With Autism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05546554.

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