What side effects are associated with this type of intervention?

Common treatments for Autism Spectrum Disorder (ASD) that involve antioxidant and glutamate modulation, such as N-acetylcysteine (NAC), generally have a favorable safety profile. NAC is well-tolerated, but some studies have reported gastrointestinal issues like nausea and diarrhea. Omega-3 fatty acids, another antioxidant therapy, can also cause gastrointestinal distress, including nausea and diarrhea, and should be used cautiously in patients with bleeding disorders or fish allergies. Overall, these treatments are considered to have low risk, but their benefits for core ASD symptoms remain uncertain.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically targeting antioxidant and glutamate modulation for Autism Spectrum Disorder (ASD). While N-acetylcysteine (NAC) is being studied for its potential benefits in reducing symptom severity in ASD due to its antioxidant properties and ability to modulate glutamate, it has not yet received FDA approval for this indication. Other drugs like memantine, which targets glutamate neurotransmission, have been studied but have not demonstrated sufficient efficacy in clinical trials to gain FDA approval for ASD treatment.

What other types of research exist?

Promising novel alternatives to N-acetylcysteine (NAC) for Autism Spectrum Disorder (ASD) patients include: 1. Omega-3 fatty acids: Although evidence is inconsistent, some studies suggest small beneficial effects on language, social deficits, and associated symptoms. 2. Memantine: While not effective in all trials, it has shown potential in some studies and is well-tolerated. 3. Acetyl-DL-leucine: Demonstrated potential in case series for cerebellar diseases, which may have implications for ASD treatment. These alternatives should be discussed with a healthcare provider to determine the best course of action.

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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

Summary

This trial tests NAC, a safe nutritional supplement, to see if it can reduce repetitive behaviors in children with autism by balancing brain chemicals.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and week 12

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

N-acetylcysteine (NAC) is an antioxidant that reduces oxidative stress by replenishing glutathione levels and modulates glutamate by affecting the cystine-glutamate antiporter. This dual action is significant for Autism Spectrum Disorder (ASD) patients because oxidative stress and glutamate dysregulation are thought to contribute to core ASD symptoms, including social impairment and repetitive behaviors. By addressing these underlying mechanisms, NAC and similar treatments may help alleviate these symptoms, potentially improving the quality of life for individuals with ASD.

A randomised, double blind, placebo-controlled trial of a fixed dose of N-acetyl cysteine in children with autistic disorder.N-acetylcysteine for treatment of autism, a case report.

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Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,467 Previous Clinical Trials

17,496,067 Total Patients Enrolled

36 Trials studying Autism Spectrum Disorder

3,789 Patients Enrolled for Autism Spectrum Disorder

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

2,043 Previous Clinical Trials

2,730,241 Total Patients Enrolled

36 Trials studying Autism Spectrum Disorder

10,003 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

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