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Trial of Zolpidem for Sleep in Children With Autism

Primary Purpose

Autism, Autism Spectrum Disorder

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Zolpidem

Placebo

About this trial

This is an interventional basic science trial for Autism focused on measuring zolpidem, sleep, clinical trial, autism

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Participants will meet the following

Outpatients between 8 and 17 years of age with only 12 to 17 years of age during year 1
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 Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2)
Males and females
Availability of polysomnography (PSG) and actigraphy data
Sleep disturbances as assessed using Children's Sleep Habits Questionnaire (CSHQ) with a score of 41 or higher and sleep efficiency of 80% or less
care provider who can reliably bring participant to clinic visits, provide trustworthy ratings, and interacts with participant on a regular basis
stable medications for at least 4 weeks
no planned changes in psychosocial and biomedical interventions during the trial
willingness to provide additional saliva samples and participate in key study procedures (i.e., PSG and actigraphy at week 4 and 8, and safety measurements every visit)
requirement of dual protection contraception use in females who are sexually active and are of childbearing potential. Dual use contraceptive methods involve the use of both a hormonal method (oral contraceptives, long-acting reversible contraceptives, etc.) and a barrier method (condoms).

Exclusion criteria:

Participants will be excluded if one or more of the following is met

active suicidal ideation or DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder
active medical problems: migraine, asthma, seizure disorder, significant physical illness (e.g., anaphylaxis, serious liver, renal, or cardiac pathology), and hepatic insufficiency
evidence of a genetic mutation known to cause autism or intellectual disability (e.g., Fragile X Syndrome), metabolic, or infectious etiology for the participant's autism on the basis of medical history, neurologic history, and available tests for inborn errors of metabolism and chromosomal analysis
pregnant or sexually active females not using a reliable method of contraception (urinary tests for pregnancy will be employed in this study)
individuals taking beta-blockers (local or systemic), benzodiazepines, antiepileptic medications, serotonin selective re-uptake inhibitors, melatonin, antihistamines and antidepressants
history of hypersensitivity to zolpidem
history of severe side effects from zolpidem
history of adequate trial of zolpidem
current use of any medications known to interact with zolpidem such as medications inhibiting CYP3A4 and CYP1A2
history of complex sleep-related behaviors
individuals using alcohol, marijuana and other substances.

Sites / Locations

Stanford UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Zolpidem, then Placebo

Placebo, then Zolpidem

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in sleep architecture as measured by polysomnography (PSG), examples include sleep latency and non-rapid eye movement (NREM)

Secondary Outcome Measures

Change from baseline in sleep efficiency as measured by actigraphy

Full Information

NCT ID

NCT05540574

First Posted

September 12, 2022

Last Updated

September 5, 2023

Sponsor

Stanford University

Collaborators

National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT05540574

Brief Title

Trial of Zolpidem for Sleep in Children With Autism

Official Title

Randomized Placebo-Controlled Crossover Trial of Zolpidem for Sleep in Children With Autism

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 9, 2023 (Actual)

Primary Completion Date

April 30, 2027 (Anticipated)

Study Completion Date

April 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to examine the effect of zolpidem on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Zolpidem is a nonbenzodiazepine GABAa receptor agonist drug that acts as a hypnotic. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of zolpidem on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism, Autism Spectrum Disorder

Keywords

zolpidem, sleep, clinical trial, autism

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Zolpidem, then Placebo

Arm Type

Experimental

Arm Description

Arm Title

Placebo, then Zolpidem

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Zolpidem

Other Intervention Name(s)

Ambien

Intervention Description

5mg (and up to10mg) Diphenhydramine given orally

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching Placebo given orally

Primary Outcome Measure Information:

Title

Change from baseline in sleep architecture as measured by polysomnography (PSG), examples include sleep latency and non-rapid eye movement (NREM)

Time Frame

Baseline, Week 4 and Week 8

Secondary Outcome Measure Information:

Title

Change from baseline in sleep efficiency as measured by actigraphy

Time Frame

Baseline, Week 4 and Week 8

Other Pre-specified Outcome Measures:

Title

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

Time Frame

Baseline, Week 4 and Week 8

Title

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

Time Frame

Baseline, Week 4 and Week 8

Title

Change from baseline on Parent Sleep Habits Questionnaire Parent (PSHQ) scores

Time Frame

Baseline, Week 4 and Week 8

Title

Change from baseline on Clinical Global Impression Scale (CGI) scores

Time Frame

Baseline, Week 4 and Week 8

Title

Change from baseline on Child Behavior Checklist (CBCL) scores

Time Frame

Baseline, Week 4 and Week 8

Title

Change from baseline on Social Responsiveness Scale, Second Edition (SRS-2) scores

Time Frame

Baseline, Week 4 and Week 8

Title

Change from baseline on Repetitive Behavior Scale - Revised (RBS-R) scores

Time Frame

Baseline, Week 4 and Week 8

Title

Change from baseline on Sensory Profile Questionnaire (SPQ) scores

Time Frame

Baseline, Week 4 and Week 8

Title

Change from baseline on Stanford Social Dimension Scale (SSDS) scores

Time Frame

Baseline, Week 4 and Week 8

Title

Change from baseline on Dimensional Assessment of Repetitive Behaviors (DARB) scores

Time Frame

Baseline, Week 4 and Week 8

Title

Change from baseline on NEuroPSYchological Assessment, 2nd Edition (NEPSY-2) Affect Recognition scores

Time Frame

Baseline, Week 4 and Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Participants will meet the following Outpatients between 8 and 17 years of age with only 12 to 17 years of age during year 1 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 Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2) Males and females Availability of polysomnography (PSG) and actigraphy data Sleep disturbances as assessed using Children's Sleep Habits Questionnaire (CSHQ) with a score of 41 or higher and sleep efficiency of 80% or less care provider who can reliably bring participant to clinic visits, provide trustworthy ratings, and interacts with participant on a regular basis stable medications for at least 4 weeks no planned changes in psychosocial and biomedical interventions during the trial willingness to provide additional saliva samples and participate in key study procedures (i.e., safety measurements every visit, PSG at weeks 4 and 8, and wear the actigraphy watch for 2 weeks before the beginning of trial as well as during the 8 weeks of the trial) requirement of dual protection contraception use in females who are sexually active and are of childbearing potential. Dual use contraceptive methods involve the use of both a hormonal method (oral contraceptives, long-acting reversible contraceptives, etc.) and a barrier method (condoms). Exclusion criteria: Participants will be excluded if one or more of the following is met active suicidal ideation or DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder active medical problems: migraine, asthma, seizure disorder, significant physical illness (e.g., anaphylaxis, serious liver, renal, or cardiac pathology), and hepatic insufficiency evidence of a genetic mutation known to cause autism or intellectual disability (e.g., Fragile X Syndrome), metabolic, or infectious etiology for the participant's autism on the basis of medical history, neurologic history, and available tests for inborn errors of metabolism and chromosomal analysis pregnant or sexually active females not using a reliable method of contraception (urinary tests for pregnancy will be employed in this study) individuals taking beta-blockers (local or systemic), benzodiazepines, antiepileptic medications, serotonin selective re-uptake inhibitors, melatonin, antihistamines and antidepressants history of hypersensitivity to zolpidem history of severe side effects from zolpidem history of adequate trial of zolpidem current use of any medications known to interact with zolpidem such as medications inhibiting CYP3A4 and CYP1A2 history of complex sleep-related behaviors individuals using alcohol, marijuana and other substances.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joe McGrath, BS

Phone

(650) 736-1235

roscoe37@stanford.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Richard Ellks, MS

Phone

(650) 736-1235

ACESleepTrials@stanford.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Antonio Y. Hardan, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

94305-5719

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joe McGrath

Phone

650-736-1235

roscoe37@stanford.edu

First Name & Middle Initial & Last Name & Degree

Richard Ellks

Phone

(650) 736-1235

ACESleepTrials@stanford.edu

First Name & Middle Initial & Last Name & Degree

Antonio Y. Hardan, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

We will submit de-identified clinical data to the NIMH Data Archive (NDA) data repository.

IPD Sharing URL

https://nda.nih.gov/nda/data-contribution.html

Learn more about this trial

Trial of Zolpidem for Sleep in Children With Autism

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