Ignite Creation Date:
2024-05-06 @ 9:33 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03008889
Status:
COMPLETED
Last Update Posted:
2021-01-26
First Post:
2016-12-28
Brief Title:
A Feasibility Study of N-acetylcysteine for Self-injurious Behavior in Children With Autism Spectrum Disorder
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
A Feasibility Study of N-acetylcysteine for Self-injurious Behavior in Children With Autism Spectrum Disorder
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAC
Brief 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
Detailed Description:
Self-injurious behavior SIB in children with autism spectrum disorder ASD can cause physical harm to the child and interfere with the childs ability to make use of educational programs and helpful treatments such as speech therapy The turmoil caused by self-injurious behaviors in children with ASD invariably interferes with daily routines because family life often stops during these episodes and family members worry about setting off SIB between episodes This project will use the detailed assessment methods developed in the field of behavior therapy to evaluate the potential for N-acetylcysteine NAC to treat children with ASD and moderate repetitive SIB NAC is an over-the-counter dietary supplement that may have beneficial effects on the brain through its well-documented antioxidant effects andor reduced glutamate signaling In the proposed study 14 children with ASD and repetitive SIB between the ages of 5 and 12 will be randomly assigned to gradually increasing doses of NAC or placebo for 9 weeks The research team parents and children will be blind to the treatment with NAC or placebo Participants will come to the research site periodically to complete measures and behavioral assessments
After the 9 weeks of treatment children randomized to NAC who showed improvement will be encouraged to continue taking the supplement outside the study Children who were randomly assigned to the placebo and showed no improvement will be offered open-label treatment with NAC Children who did not improve while taking NAC or those who improved while on the placebo will be advised on next steps by the study team
The goal of this feasibility study is establish the acceptability viability of study procedures in this vulnerable population to learn about the potential benefits and adverse effects of NAC Demonstrating these feasibility aims and the preliminary efficacy and safety of NAC is a prerequisite for planning a larger more definitive study
After the 9 weeks of treatment children randomized to NAC who showed improvement will be encouraged to continue taking the supplement outside the study Children who were randomly assigned to the placebo and showed no improvement will be offered open-label treatment with NAC Children who did not improve while taking NAC or those who improved while on the placebo will be advised on next steps by the study team
The goal of this feasibility study is establish the acceptability viability of study procedures in this vulnerable population to learn about the potential benefits and adverse effects of NAC Demonstrating these feasibility aims and the preliminary efficacy and safety of NAC is a prerequisite for planning a larger more definitive study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None