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

Primary Purpose

Autism Spectrum Disorder

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

N-Acetylcysteine

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Magnetic Resonance Imaging, N-acetylcysteine, Restricted and Repetitive Behaviors, electroencephalography

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

aged between 3 years and 12 years 11 months,
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.

Sites / Locations

Stanford University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

N-acetylcysteine then Placebo

Placebo then N-acetylcysteine

Arm Description

Outcomes

Primary Outcome Measures

Change in glutamatergic neurometabolites (Glx) measured by proton spectroscopy Magnetic Resonance Imaging (MRI)

Secondary Outcome Measures

Change in Gamma band amplitude and synchronization measured by electroencephalography

Full Information

NCT ID

NCT04278898

First Posted

February 18, 2020

Last Updated

July 11, 2023

Sponsor

Stanford University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04278898

Brief Title

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

Official Title

Targeting the Neurobiology of Restricted and Repetitive Behaviors in Children With Autism Using N-acetylcysteine: a Single-dose Challenge Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 12, 2021 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

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

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 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.

6. Conditions and Keywords

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

Autism Spectrum Disorder

Keywords

Magnetic Resonance Imaging, N-acetylcysteine, Restricted and Repetitive Behaviors, electroencephalography

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

N-acetylcysteine then Placebo

Arm Type

Experimental

Arm Title

Placebo then N-acetylcysteine

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

N-Acetylcysteine

Intervention Description

N-acetylcysteine Single Dose 2700 mg taken orally

Primary Outcome Measure Information:

Title

Change in glutamatergic neurometabolites (Glx) measured by proton spectroscopy Magnetic Resonance Imaging (MRI)

Time Frame

1 hour after single dose

Secondary Outcome Measure Information:

Title

Change in Gamma band amplitude and synchronization measured by electroencephalography

Time Frame

1 hour after single dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: aged between 3 years and 12 years 11 months, 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.

Central Contact Person:

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

Katie Hodges, MS

Phone

(650) 723-7845

autismresearch@stanford.edu

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

Robin Libove, BA

Phone

(650) 736-1235

rlibove@stanford.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Hegarty, PhD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

John Hegarty, PhD

Phone

650-736-1235

hegartyj@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

IPD Sharing Time Frame

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

IPD Sharing Access Criteria

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

IPD Sharing URL

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

Learn more about this trial

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

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