Targeting the Neurobiology of RRB in Autism Using N-acety... | NCT04278898

Studies
Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Single-dose

NCT04278898

Sponsor

Stanford University

Status

Recruiting

Last Update Posted

May 15, 2026Actual

Enrollment

24Estimated

Phase

Phase 2

Conditions

Autism Spectrum Disorder

Interventions

N-Acetylcysteine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1K99HD101702	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 12, 2021Actual

Primary Completion Date

Jul 31, 2028Estimated

Completion Date

Jan 31, 2029Estimated

First Submitted Date

Feb 18, 2020

First Submission Date that Met QC Criteria

Feb 18, 2020

First Posted Date

Feb 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2026

Last Update Posted Date

May 15, 2026Actual

Name	Class
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this study is to target the neurobiology of restricted and repetitive behaviors in children with autism spectrum disorder using N-acetylcysteine (NAC), a well-tolerated nutritional supplement that has shown promise for reducing symptom severity in recent small-scale trials. The findings from this research will shed light on the mechanisms of action underlying the clinical benefits of NAC.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
N-acetylcysteine then Placebo	Experimental		Drug: N-Acetylcysteine
Placebo then N-acetylcysteine	Experimental		Drug: N-Acetylcysteine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
N-Acetylcysteine	Drug	N-acetylcysteine Single Dose 2700 mg taken orally	N-acetylcysteine then Placebo Placebo then N-acetylcysteine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in glutamatergic neurometabolites (Glx) measured by proton spectroscopy Magnetic Resonance Imaging (MRI)		1 hour after single dose

Secondary Outcomes

Measure	Description	Time Frame
Change in Gamma band amplitude and synchronization measured by electroencephalography		1 hour after single dose

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

children between 3 years and 12 years 11 months at the time of consent
diagnosis of Autism Spectrum Disorder confirmed with the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule-2 (ADOS-2), or Brief Observation of Symptoms of Autism (BOSA), or Childhood Autism Rating Scale- Second Edition (CARS-2).
at least moderate Restricted and Repetitive Behaviors severity defined by a Children's Yale-Brown Obsessive Compulsive Scale for children with autism spectrum disorder score ≥ 11,
physical development indicative of prepubescence as defined by the criteria for Tanner Stage 1,
medically stable,
passes MR safety screening (e.g., no metal in the body).

Exclusion Criteria:

presence of known genetic abnormalities associated with Autism Spectrum Disorder (e.g. Fragile X),
current or life-time diagnosis of severe psychiatric disorder (e.g., schizophrenia),
presence of significant medical problems that would interfere with participation,
the inability of at least one caregiver to speak/read English to a sufficient level to complete study requirements and materials,
individuals taking antioxidant agents and glutathione prodrugs, or
the inability/unwillingness to swallow an agent during the screening visit.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ramy Chebbo	Contact	(650) 723-7845		autismresearch@stanford.edu
John Hegarty, PhD	Contact	(650) 723-7845		hegartyj@stanford.edu

Overall Officials

Name	Affiliation	Role
John Hegarty, PhD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine	Recruiting	Stanford	California	94305	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

De-Identified data will be shared with the National Database for Autism Research (NDAR)

Types

Not provided

Time Frame

The data will be submitted on January 15th and July 15th each year.

Access Criteria

Researchers with access to the National Database for Autism Research (NDAR) will be able to obtain the submitted data.

URL

https://nda.nih.gov/contribute/sharing-regimen.html

ID	Term
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

ID	Term
D003545	Cysteine
D000603	Amino Acids, Sulfur
D013457	Sulfur Compounds
D009930	Organic Chemicals