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Nutritional Supplement

N-acetylcysteine for Autism

Phase 2 & 3
Recruiting
Led By John Hegarty, PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 12
Awards & highlights

Study Summary

This trial will examine the effects of NAC on restricted and repetitive behaviors in children with autism, using a double-blind, placebo-controlled study. Results may help explain how NAC can reduce symptom severity.

Who is the study for?
This trial is for children aged 3 to almost 13 with autism, who show moderate to severe repetitive behaviors. They must be medically stable, not have metal implants (for MRI safety), and be in early physical development stages. Kids should be on steady medication and treatment plans for at least a month before the trial starts, with no changes expected during the study.Check my eligibility
What is being tested?
The study tests N-acetylcysteine (NAC), a nutritional supplement against a placebo over 12 weeks to see if it can reduce restricted and repetitive behaviors in autistic children. It's double-blind, meaning neither researchers nor participants know who gets NAC or placebo, ensuring unbiased results.See study design
What are the potential side effects?
While specific side effects are not listed here, N-acetylcysteine is generally well-tolerated. Possible side effects might include gastrointestinal discomfort or allergic reactions but will vary based on individual responses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Children's Yale Brown-Obsessive Compulsive Scale for Autism Spectrum Disorder (CYBOCS-ASD) at 12 weeks
Change in Glutamatergic neurometabolites at 12 weeks
Secondary outcome measures
Change in Gamma band activity at 12 weeks
Change in Restricted and Repetitive Behavior Scale Revised (RBS-R) at 12 weeks

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: N-acetylcysteineActive Control1 Intervention
12 week administration of active study compound
Group II: PlaceboPlacebo Group1 Intervention
12 week administration of matched placebo

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,406 Previous Clinical Trials
17,343,097 Total Patients Enrolled
33 Trials studying Autism Spectrum Disorder
4,049 Patients Enrolled for Autism Spectrum Disorder
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,976 Previous Clinical Trials
2,680,698 Total Patients Enrolled
34 Trials studying Autism Spectrum Disorder
9,676 Patients Enrolled for Autism Spectrum Disorder
John Hegarty, PhDPrincipal InvestigatorStanford University
2 Previous Clinical Trials
72 Total Patients Enrolled
2 Trials studying Autism Spectrum Disorder
72 Patients Enrolled for Autism Spectrum Disorder

Media Library

N-acetylcysteine (Nutritional Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05664789 — Phase 2 & 3
Autism Spectrum Disorder Research Study Groups: N-acetylcysteine, Placebo
Autism Spectrum Disorder Clinical Trial 2023: N-acetylcysteine Highlights & Side Effects. Trial Name: NCT05664789 — Phase 2 & 3
N-acetylcysteine (Nutritional Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05664789 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the participant criteria for this trial open to individuals beyond age forty?

"This medical trial stipulates that participants must have a minimum age of 3 and must not exceed the age of 12."

Answered by AI

Who can partake in this clinical trial?

"Applicants who meet the criteria of having autism and ranging in age from 3 to 12 may participate in this medical trial. Currently, 48 patients are being accepted as part of this study."

Answered by AI

How many participants are included in this clinical research?

"Indeed, the information posted on clinicaltrials.gov confirms that this medical trial is actively recruiting participants. The investigation was first made public on February 1st 2023 and has since been updated as of September 2nd 2023. At present, 48 patients are being enrolled from a single site."

Answered by AI

Is this experiment actively seeking participants at the moment?

"Confirmed. According to clinicaltrials.gov, this research project is still actively seeking participants and was first posted on February 1st 2023 with its most recent update coming on the 9th of that same month. The investigators are hoping to recruit 48 individuals from a single site."

Answered by AI
~29 spots leftby Jan 2026