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NCT03008889 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Autism Spectrum Disorder, sponsored by Emory University.

Completed
Registry status
Phase 2
Development phase
8
Enrollment target
1
Study location

NCT03008889: Completed Phase 2 study of Autism Spectrum Disorder, sponsored by Emory University.

NCT03008889 is a Phase 2 study of Autism Spectrum Disorder that has completed, run by Emory University. The registered enrollment target is 8 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03008889, a Phase 2 study of Autism Spectrum Disorder, has completed, sponsored by Emory University.

COMPLETED
Registry status
Phase 2
Development phase
8 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Goal: randomize 1.75 participants per month

Conditions Studied

Autism Spectrum Disorder

Interventions

  • DRUG Placebo
  • DRUG N-acetylcysteine

Study Locations (1)

Georgia

  • Marcus Autism Center - Atlanta

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2018-07-05
Est. Completion 2019-09-12
Phase Phase 2
Emory University

1,208 total trials

What the finished NCT03008889 record still lists

NCT03008889 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (94% lower).

The record links to 1 condition, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03008889 reports a single indexed study location in Georgia.

Frequently Asked Questions

What is clinical trial NCT03008889 about?

NCT03008889 is a clinical study titled "A Feasibility Study of N-acetylcysteine for Self-injurious Behavior in Children With Autism Spectrum Disorder". 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 eval...

What is the current status of trial NCT03008889?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2018-07-05. Estimated completion is 2019-09-12.

What conditions does trial NCT03008889 study?

This clinical trial studies the following conditions: Autism Spectrum Disorder.

What interventions are being tested in trial NCT03008889?

The interventions under investigation include: Placebo (DRUG), N-acetylcysteine (DRUG).

Who is sponsoring clinical trial NCT03008889?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03008889 being conducted?

This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Autism Spectrum Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03008889's enrollment target sits among peer trials

8 221st of 224 higher than 2 of 224 other Autism Spectrum Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03008889, the US trial registry maintained by the National Library of Medicine. NCT03008889 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.