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N-Acetylcysteine for Autism

Phase 2
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
diagnosis of Autism Spectrum Disorder confirmed with the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule-2 (ADOS-2), or Brief Observation of Symptoms of Autism (BOSA), or Childhood Autism Rating Scale- Second Edition (CARS-2).
aged between 3 years and 12 years 11 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 hour after single dose
Awards & highlights

Study Summary

This trial will study whether N-acetylcysteine can help reduce repetitive behaviors in children with autism spectrum disorder.

Who is the study for?
This trial is for children aged 3 to almost 13 with Autism Spectrum Disorder, confirmed by specific diagnostic tests. They must be medically stable, prepubescent, and have moderate to severe repetitive behaviors. Kids can't join if they have metal in their body (unsafe for MRI), genetic abnormalities like Fragile X, or take certain antioxidants.Check my eligibility
What is being tested?
The study is testing N-acetylcysteine (NAC), a nutritional supplement that might help reduce the severity of restricted and repetitive behaviors in autistic children. The research aims to understand how NAC affects these symptoms.See study design
What are the potential side effects?
While not specified here, NAC is generally well-tolerated but could potentially cause side effects such as gastrointestinal discomfort, rash, headache or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My autism diagnosis was confirmed with specific autism assessment tools.
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I am between 3 and 12 years old.
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My physical development shows I am in the earliest stage of puberty.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour after single dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hour after single dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body Weight Changes
Secondary outcome measures
Change in Gamma band amplitude and synchronization measured by electroencephalography

Side effects data

From 2015 Phase 3 trial • 302 Patients • NCT01675661
7%
Headache
5%
Nausea
5%
Diarrhea
2%
Abdominal discomfort
2%
Dyspepsia
2%
Pruritis
1%
Arthropod bite
1%
Alcohol abuse
1%
Road traffic accident
1%
Cellulitis
1%
Gastrointestinal disorder
1%
Abdominal pain
1%
Vomiting
1%
Reflux disease
1%
Dizziness
1%
Insomnia
1%
Rash
1%
Energy increased
1%
Groin Abscess
1%
Flushing
1%
Fatigue
1%
Panic attack
1%
Depression
1%
Blood pressure increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
NAC Plus CM
Placebo Plus CM

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo then N-acetylcysteineExperimental Treatment1 Intervention
Group II: N-acetylcysteine then PlaceboExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
N-Acetylcysteine
2013
Completed Phase 3
~1470

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 a treatment being studied for Autism Spectrum Disorder (ASD) due to its antioxidant properties and its ability to modulate glutamate levels. NAC works by disrupting disulfide bonds, which helps to liquefy mucus and DNA, and by acting as an antioxidant, reducing oxidative stress. Additionally, NAC modulates glutamate levels, which is crucial because glutamate is a key neurotransmitter involved in brain function and its dysregulation is often observed in ASD. These mechanisms are important for ASD patients as they may help reduce symptom severity, including social impairment and aggressive behaviors, thereby potentially improving quality of life.
N-acetylcysteine for treatment of autism, a case report.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,410 Previous Clinical Trials
17,343,367 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,988 Previous Clinical Trials
2,683,315 Total Patients Enrolled
John Hegarty, PhDPrincipal InvestigatorStanford University
2 Previous Clinical Trials
96 Total Patients Enrolled

Media Library

N-Acetylcysteine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04278898 — Phase 2
Autism Research Study Groups: Placebo then N-acetylcysteine, N-acetylcysteine then Placebo
Autism Clinical Trial 2023: N-Acetylcysteine Highlights & Side Effects. Trial Name: NCT04278898 — Phase 2
N-Acetylcysteine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04278898 — Phase 2
~1 spots leftby Aug 2024