Zolpidem for Autism Spectrum Disorder

Q: Is there an age-restriction for enrollment in this research experiment?

<p>This research study <a href="https://www.withpower.com/clinical-trials/all">all</a>ows for volunteers between the ages of 8 and 17, in accordance with its eligibility requirements.</p>

Stanford University, Stanford, CA

Targeting 3 different conditionsZolpidem +1 morePhase 2RecruitingLed by Antonio Y. Hardan, MDResearch Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Males and females

Be younger than 18 years old

Must not have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upbaseline, week 4 and week 8

Awards & highlights

Study Summary

This trial is studying how a drug (zolpidem) affects sleep in kids and teens with autism, using techniques like polysomnography and actigraphy.

Eligible Conditions

Autism Spectrum Disorder
Autism

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

Both males and females can participate.

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

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 score

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Zolpidem, then PlaceboExperimental Treatment2 Interventions

Participants will first receive Zolpidem for a 4-week period. A 5 mg dose of Zolpidem will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated. Participants will then receive Placebo (fake tablet) for a 4-week period. A 5 mg dose of matching Placebo will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated.

Group II: Placebo, then ZolpidemExperimental Treatment2 Interventions

Participants will first receive Placebo (fake tablet) for a 4-week period. A 5 mg dose of matching Placebo will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated. Participants will then receive Zolpidem for a 4-week period. A 5 mg dose of Zolpidem will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zolpidem

2003

Completed Phase 4

~2530

Placebo

1995

Completed Phase 3

~2670

0 / 1Eligibility criteria met

Find a site

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,258 Previous Clinical Trials

17,273,614 Total Patients Enrolled

31 Trials studying Autism Spectrum Disorder

3,119 Patients Enrolled for Autism Spectrum Disorder

National Institutes of Health (NIH)NIH

2,595 Previous Clinical Trials

6,796,805 Total Patients Enrolled

20 Trials studying Autism Spectrum Disorder

2,419 Patients Enrolled for Autism Spectrum Disorder

Antonio Y. Hardan, MDPrincipal Investigator

Stanford University

8 Previous Clinical Trials

425 Total Patients Enrolled

7 Trials studying Autism Spectrum Disorder

377 Patients Enrolled for Autism Spectrum Disorder

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05540574 — Phase 2

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

Autism Spectrum Disorder Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05540574 — Phase 2

Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05540574 — Phase 2

Frequently Asked Questions

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

Is there an age-restriction for enrollment in this research experiment?

"This research study allows for volunteers between the ages of 8 and 17, in accordance with its eligibility requirements."

Answered by AI

Has Zolpidem been given the green light by the FDA?

"Our assessment of Zolpidem's safety falls at a 2 as there is limited evidence indicating its efficacy, though much more exists in regards to the drug's security."

Answered by AI

Could you provide an estimate of the people enrolled in this medical experiment?

"Affirmative. Clinicaltrials.gov data shows that this medical inquiry, which was first posted on July 12th 2023, is actively seeking new participants. Approximately 26 individuals must be recruited from a single site."

Answered by AI

Is enrollment for this medical experiment currently available?

"Confirmed, this clinical trial is actively recruiting participants. Initially posted on July 12th 2023 with a recent update occurring the following day; information can be found on clinicaltrials.gov."

Answered by AI

What eligibility requirements must be met to participate in this trial?

"This experiment is seeking 26 children aged 8-17 with Autism Spectrum Disorder (ASD). Necessary criteria for enrolment include: outpatient status between ages 8 and 17 during year one, DSM-5 diagnosis of ASD confirmed by the ADI-R and the ADOS-2 tests, gender non specific, PSG data available as well as actigraphy results from a CSHQ score higher than 41 with a sleep efficiency lower than 80%, reliable care providers to interact regularly with participants and accompany them to appointments while maintaining stable medication regimens for 4 weeks or more, willingness to provide saliva samples and take part in key procedures such as"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial of Zolpidem for Sleep in Children With Autism

Antonio Hardan 2023. "Trial of Zolpidem for Sleep in Children With Autism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05540574.