drugset / Trial / NCT03008889

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

NCT03008889

Phase 2 Completed 8 enrolled Emory University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2018-07-05
Primary completion
2019-09-12
Completion
2019-09-12

Drugs

EvaluationDrugModalityDoseRoute
Subject N-acetylcysteine Small molecule 900 mg Oral