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Nutritional Supplement

N-acetylcysteine for Autism

Phase 2 & 3
Waitlist Available
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, week 8, week 12
Awards & highlights

Study Summary

This trial studies how a nutritional supplement called N-acetylcysteine can reduce symptoms of autism spectrum disorder, like restricted and repetitive behaviors. Results will help understand how NAC works & its effects.

Who is the study for?
This trial is for children aged 3 to under 13 with autism spectrum disorder, confirmed by specific diagnostic tools. They must be prepubescent, medically stable, and have no metal in their body that would interfere with MRI or EEG tests. Participants should be on a steady medication and treatment plan for at least 30 days before the trial starts and not expected to change during the trial.Check my eligibility
What is being tested?
The study is testing N-acetylcysteine (NAC), a nutritional supplement thought to help reduce symptoms of autism, particularly restricted and repetitive behaviors. The research aims to understand how NAC works in the brain of children with autism.See study design
What are the potential side effects?
While not specified here, common side effects of N-acetylcysteine may include nausea, vomiting, rash, and fever. As it's well-tolerated generally, severe side effects are rare but can occur.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 8, week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 8, 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 glutamatergic neurometabolites (Glx) measured by proton spectroscopy Magnetic Resonance Imaging (MRI)
Change in restricted and repetitive behaviors as measured by Children's Yale Brown Obsessive Compulsive Scale - Autism Spectrum Disorder (CYBOCS-ASD)
Secondary outcome measures
Change in Gamma band amplitude and synchronization measured by electroencephalography (EEG)
Change in restricted repetitive behavior subtypes as measured by the Restricted Behavior Scale - Revised (RBS-R)

Trial Design

1Treatment groups
Experimental Treatment
Group I: N-AcetylcysteineExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
N-acetylcysteine
2008
Completed Phase 4
~1290

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,393 Previous Clinical Trials
17,341,144 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,674,682 Total Patients Enrolled
John Hegarty, PhDPrincipal InvestigatorStanford University
2 Previous Clinical Trials
72 Total Patients Enrolled

Media Library

N-acetylcysteine (Nutritional Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05494398 — Phase 2 & 3
Autism Research Study Groups: N-Acetylcysteine
Autism Clinical Trial 2023: N-acetylcysteine Highlights & Side Effects. Trial Name: NCT05494398 — Phase 2 & 3
N-acetylcysteine (Nutritional Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05494398 — Phase 2 & 3

Frequently Asked Questions

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

Does the age criteria for this experiment extend beyond 45 years of age?

"This trial is recruiting children aged between 3 and 12 years old."

Answered by AI

Is enrollment now open for this trial?

"According to the details published on clinicaltrials.gov, this research study is not currently open for enrolment as it was initially posted on November 15th 2022 and last updated December 7th 2022. Nonetheless, 271 other trials are actively recruiting patients right now."

Answered by AI

Who else is applying?

What site did they apply to?
Stanford University School of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

Son rocky was diagnosed with autism and wanted to.find help for his symptoms.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Open Label
John Patrick Hegarty 2022. "Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Open Label". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05494398.
~32 spots leftby Sep 2027
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