A Feasibility Study of N-acetylcysteine for Self-injurious Behavior in Children With Autism Spectrum Disorder

Completed · Phase 2 · Has a placebo group

Conditions studied: Autism Spectrum Disorder

In brief

The purpose of this study is to demonstrate the feasibility of a 9-week, randomized trial of N-acetylcysteine (NAC) compared to placebo in 14 children (age 5 to 12 years) with Autism Spectrum Disorder (ASD) and a moderate level of repetitive self-injurious behavior (SIB). Additional aims are to evaluate the positive predictive value of a screening method to classify children with automatically maintained self-injurious behavior; to evaluate the preliminary efficacy of NAC for reducing repetitive SIB in children with ASD; and to evaluate biomarkers and possible mechanisms of action of NAC in children with ASD.

Key facts

Study ID

NCT03008889

Run by

Emory University

People needed

8

Starts

2018-07-05

Expected to finish

2019-09-12

Last updated by the study team

2021-01-26

Who can join

Age: 5 and older, up to 12. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Confirmed diagnosis of Autism Spectrum Disorder (ASD)
• Confirmed presence of moderate Self Injurious Behavior (SIB)
• Score > 16 on the parent-rated Aberrant Behavior Checklist Irritability subscale (moderate level of disruptive behavior)
• Classified as having automatically maintained SIB (determined during screening by a detailed functional analysis)

You may not qualify if…

• On a stable medication dose for less than 4 weeks
• Planned change in medication during the 9-week trial
• Had one or more seizures in the last 6 months

Where it is running

• Marcus Autism Center — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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