N-Acetylcysteine for Autism Spectrum Disorder

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Autism Spectrum Disorder+2 More
N-Acetylcysteine - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Autism Spectrum Disorder
  • Autism Spectrum Disorders

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Autism Spectrum Disorder

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 1 hour after single dose

Hour 1
Change in Gamma band amplitude and synchronization measured by electroencephalography
Body Weight Changes

Trial Safety

Safety Progress

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

Other trials for Autism Spectrum Disorder

Side Effects for

NAC Plus CM
7%Headache
5%Nausea
5%Diarrhea
2%Dyspepsia
2%Abdominal discomfort
2%Pruritis
1%Depression
1%Cellulitis
1%Arthropod bite
1%Alcohol abuse
1%Gastrointestinal disorder
1%Reflux disease
1%Vomiting
1%Road traffic accident
1%Rash
1%Dizziness
1%Blood pressure increased
1%Flushing
1%Abdominal pain
1%Insomnia
1%Fatigue
1%Panic attack
1%Energy increased
1%Groin Abscess
This histogram enumerates side effects from a completed 2015 Phase 3 trial (NCT01675661) in the NAC Plus CM ARM group. Side effects include: Headache with 7%, Nausea with 5%, Diarrhea with 5%, Dyspepsia with 2%, Abdominal discomfort with 2%.

Trial Design

2 Treatment Groups

Placebo then N-acetylcysteine
1 of 2
N-acetylcysteine then Placebo
1 of 2
Experimental Treatment

24 Total Participants · 2 Treatment Groups

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

Placebo then N-acetylcysteine
Drug
Experimental Group · 1 Intervention: N-Acetylcysteine · Intervention Types: Drug
N-acetylcysteine then Placebo
Drug
Experimental Group · 1 Intervention: N-Acetylcysteine · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetylcysteine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 hour after single dose

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,805 Previous Clinical Trials
2,235,219 Total Patients Enrolled
27 Trials studying Autism Spectrum Disorder
7,568 Patients Enrolled for Autism Spectrum Disorder
Stanford UniversityLead Sponsor
2,148 Previous Clinical Trials
35,679,144 Total Patients Enrolled
27 Trials studying Autism Spectrum Disorder
2,397 Patients Enrolled for Autism Spectrum Disorder
John Hegarty, PhDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
48 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
48 Patients Enrolled for Autism Spectrum Disorder

Eligibility Criteria

Age < 18 · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have at least moderate Restricted and Repetitive Behaviors.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 27th, 2021

Last Reviewed: October 14th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Pennsylvania66.7%
New York33.3%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%