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Enrolling by invitation NCT05494398

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

Phase II / Phase III Interventional Autism Spectrum Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: N-acetylcysteine.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder. Basic parameters: 3 years — 13 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Change in glutamatergic neurometabolites (Glx) measured by proton spectroscopy Magnetic Resonance Imaging (MRI) [Time frame: Baseline and Week 12 of treatment]
  • 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]
Secondary outcome measures (2)
  • Change in Gamma band amplitude and synchronization measured by electroencephalography (EEG) [Time frame: Baseline, Week 12]
  • Change in restricted repetitive behavior subtypes as measured by the Restricted Behavior Scale - Revised (RBS-R) [Time frame: Baseline, week 8, week 12]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanford University School of Medicine — Stanford

Identifiers

NCT: NCT05494398 · IRB-64292 · K99HD101702

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗