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N-Acetylcysteine for Autism

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Autism+1 MoreN-acetylcysteine - Drug
Eligibility
3 - 12
All Sexes
What conditions do you have?
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Study Summary

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.

Eligible Conditions
  • Autism

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Baseline, week 8, week 12

Week 12
Change in glutamatergic neurometabolites (Glx) measured by proton spectroscopy Magnetic Resonance Imaging (MRI)
Baseline, Week 12
Change in Gamma band amplitude and synchronization measured by electroencephalography (EEG)
Week 12
Change in restricted repetitive behavior subtypes as measured by the Restricted Behavior Scale - Revised (RBS-R)
Week 12
Change in restricted and repetitive behaviors as measured by Children's Yale Brown Obsessive Compulsive Scale - Autism Spectrum Disorder (CYBOCS-ASD)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Resveratrol
1
CG-806
1
AAV2-GDNF

Trial Design

1 Treatment Group

N-Acetylcysteine
1 of 1

Experimental Treatment

48 Total Participants · 1 Treatment Group

Primary Treatment: N-Acetylcysteine · No Placebo Group · Phase 2 & 3

N-Acetylcysteine
Drug
Experimental Group · 1 Intervention: N-acetylcysteine · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
N-acetylcysteine
2008
Completed Phase 4
~1290

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 8, week 12

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,170 Previous Clinical Trials
35,768,235 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,827 Previous Clinical Trials
2,250,090 Total Patients Enrolled
John Hegarty, PhDPrincipal InvestigatorStanford University
2 Previous Clinical Trials
72 Total Patients Enrolled

Eligibility Criteria

Age 3 - 12 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
• Inclusion criteria: successful completion of IRB protocols 54931 or 68353.
You are between 3 and 12 years 11 months.
You have successfully completed neuroimaging.
References

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