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Enrolling by Invitation

NCT Number: NCT05494398

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

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

N-acetylcysteine

Drug

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

Primary outcomes

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

    Time frame: Baseline and Week 12 of treatment

  2. Change in restricted and repetitive behaviors as measured by Children's Yale Brown Obsessive Compulsive Scale - Autism Spectrum Disorder (CYBOCS-ASD)

    Time frame: Screening, Week 8, week 12

    Higher scores on the Children's Yale Brown Obsessive Compulsive Scale - Autism Spectrum Disorder mean higher levels of restricted and repetitive behaviors (Raw Score Total Range: 0-20)

Secondary outcomes

  1. Change in Gamma band amplitude and synchronization measured by electroencephalography (EEG)

    Time frame: Baseline, Week 12

  2. Change in restricted repetitive behavior subtypes as measured by the Restricted Behavior Scale - Revised (RBS-R)

    Time frame: Baseline, week 8, week 12

    Higher scores on the Repetitive Behavior Scale- Revised mean higher levels of repetitive and restricted behaviors. (Raw Score Total Range: 0 - 129)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

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

Registry information

Official study title

Targeting the Neurobiology of Restricted and Repetitive Behaviors in Children With Autism Using N-acetylcysteine: an Open Label Extension

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Aug 10, 2022
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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