MedTrace Logo

A Study of Oral N-Acetylcysteine in Children With Autism Spectrum Disorders

NCT00453180 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2017-06-14

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine whether treatment with oral N-acetylcysteine (NAC) will improve behavior problems often associated with autism spectrum disorders.

Conditions

  • Autistic Disorder
  • Asperger Syndrome
  • Child Development Disorders, Pervasive

Interventions

DRUG

N-acetylcysteine

Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day.

DRUG

Placebo

Subjects randomized to placebo arm will receive placebo pill for duration of study.

Sponsors & Collaborators

  • National Alliance for Autism Research

    collaborator OTHER

  • Indiana University School of Medicine

    lead OTHER

Principal Investigators

  • Martin H. Plawecki, M.D. · Indiana University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-08-31
Completion
2009-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00453180 on ClinicalTrials.gov