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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
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
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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child is between 3 and 12 years old.My medications and mental health treatments have been stable for over a month.My autism diagnosis was confirmed with standard assessments.I am currently taking glutathione or related medications.I cannot drink the study medication if it's mixed in a liquid.I have a genetic condition linked to autism.My physical development is at the earliest stage of puberty.
Research Study Groups:
This trial has the following groups:- Group 1: N-acetylcysteine
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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