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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%
Road traffic accident
1%
Alcohol abuse
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

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,331 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,672,773 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

Frequently Asked Questions

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

Why is N-Acetylcysteine often given to patients?

"N-Acetylcysteine has been shown to be an effective line of treatment for corneal ulceration, acute rhinitis, and acetaminophen."

Answered by AI

How many people are being asked to participate in this clinical trial?

"That is correct. The trial, which was posted on February 12th 2021 and edited September 5th 2022, as indicated by clinicaltrials.gov, is looking for 24 patients at a single site."

Answered by AI

Has N-Acetylcysteine received the green light from the FDA?

"Since N-Acetylcysteine is in Phase 2 clinical trials, there is some data to support its safety but not yet any efficacy. Thus, we scored it as a 2."

Answered by AI

Is N-Acetylcysteine a new medication being trialed?

"As of now, there are 40 N-Acetylcysteine trials ongoing with 7 in the third stage. New york City has the most active clinical trials for this medication, but there are a total of 46 sites across the United States conducting research."

Answered by AI

Are recruitment efforts still underway for this research project?

"From what is published on clinicaltrials.gov, it seems that this trial is presently looking for 24 individuals from a solitary site. The listing was created on February 12th, 2021 and updated most recently on September 5th, 2022."

Answered by AI

Does this research study allow people who are over 25 years old to participate?

"For this particular study, only children aged 3 to 12 are eligible. Out of the 320 total clinical trials taking place, 249 involve minors and 71 involve patients that are senior citizens."

Answered by AI

Who would be best suited to help with this clinical trial?

"To be applicable for this study, potential participants must: 1) Be aged 3 to 12 years old (11 months), 2) Pass an MRI safety screening (e.g. no metal in the body), 3) Score at least an 11 on the Children's Yale-Brown Obsessive Compulsive Scale for children with autism spectrum disorder (moderate Restricted and Repetitive Behaviors severity required)."

Answered by AI

Who else is applying?

What state do they live in?
New York
Pennsylvania
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Single-dose
John Patrick Hegarty 2021. "Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Single-dose". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04278898.
All > Asd > Autism
~2 spots leftby Aug 2024
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