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Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Open Label

NCT ID: NCT05494398

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2/PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-12

Study Completion Date

2028-09-30

Brief Summary

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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 and the effects of NAC on altering restricted and repetitive behavior symptom severity in children with autism spectrum disorder.

Detailed Description

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Conditions

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Autism Spectrum Disorder

Keywords

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Magnetic Resonance Imaging N-acetylcysteine Restricted and Repetitive Behaviors Electroencephalography

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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N-Acetylcysteine

Group Type EXPERIMENTAL

N-acetylcysteine

Intervention Type DRUG

12 week administration of N-Acetylcysteine to target restricted repetitive behavior severity.

Interventions

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N-acetylcysteine

12 week administration of N-Acetylcysteine to target restricted repetitive behavior severity.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* participation in an associated single-dose (IRB-54931, NCT04278898) or randomized, controlled trial of NAC (IRB- 68353, NCT05664789).
* stable medication regimens (≥ 30 days) with no anticipated changes during the trial.

Exclusion Criteria

• the presence of significant medical problems that reduce medical stability.
Minimum Eligible Age

3 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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John Patrick Hegarty

Instructor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Hegarty, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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K99HD101702

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-64292

Identifier Type: -

Identifier Source: org_study_id