Phase 2
N=2
A Feasibility Study of N-acetylcysteine for Self-injurious Behavior in Children With Autism Spectrum Disorder
Autism Spectrum Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03008889 ↗Enrolled (actual)
2
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Percentage of Participants Randomized — 100; 100 percentage of participants randomized
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- N-acetylcysteine (Drug); Placebo (Drug)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Randomized |
100; 100 | — |
| PRIMARY Attrition Rate |
0; 0 | — |
| PRIMARY Study Medication Compliance |
1; 1 | — |
| PRIMARY Successful Collection of Outcome Measures |
1; 1 | — |
| PRIMARY Parent Satisfaction Rating |
1; 1 | — |
| SECONDARY Positive Predictive Value of Screening Method of Classifying Self-injurious Behavior (SIB) by Type. |
3 | — |
| SECONDARY Aberrant Behavior Checklist Irritability Subscale Score at Baseline and 9 Weeks Post-intervention |
31; 28; 23; 29 | — |
| SECONDARY Number of Self-Injurious Behavior Events |
219; 93; 59; 655 | — |
| SECONDARY Change in Clinical Global Impression (CGI-I) Scale at 9 Weeks Post-intervention |
2; 4 | — |
| SECONDARY Change in Biomarkers and Possible Mechanisms of Action of NAC in Children With ASD. |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03008889). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.