Trial record 13 of 62 for:    "Asperger Syndrome"

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

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Autism Research
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00453180
First received: March 27, 2007
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Autistic Disorder
Asperger Syndrome
Child Development Disorders, Pervasive
Drug: N-acetylcysteine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study of Oral N-Acetylcysteine in Children With Autism Spectrum Disorders

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Clinical Global Impression - Severity done at Screen, Baseline, and at the end of week 12 of treatment [ Time Frame: performed at screen, baseline, and end of treatment at week 12 ] [ Designated as safety issue: No ]
  • Clinical Global Impression - Improvement done at the end of weeks 4, 8, and 12 of treatment [ Time Frame: performed at end of weeks 4, 8, and 12 of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Aberrant Behavior Checklist done at Baseline and end of weeks 4, 8, and 12 [ Time Frame: Performed at end of weeks 4, 8, 12 ] [ Designated as safety issue: No ]
  • Social Responsiveness Scale done at Baseline and end of weeks 4, 8, and 12 [ Time Frame: Performed at baseline and end of weeks 4, 8, and 12 of treatment ] [ Designated as safety issue: No ]
  • Pervasive Developmental Disorder Behavior Index done at Baseline and end of week 12 [ Time Frame: Performed at Baseline and end of week 12 ] [ Designated as safety issue: No ]
  • Vineland Adaptive Behavior Scales done at Baseline and end of week 12 [ Time Frame: Performed at Baseline and end of week 12 ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: March 2007
Study Completion Date: November 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.
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.
Other Name: N-acetylcysteine
Placebo Comparator: 2
Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain in active ingredients.
Drug: Placebo
Subjects randomized to placebo arm will receive placebo pill for duration of study.

Detailed Description:

Autism is increasingly being recognized as a common disorder with enormous public health significance. The core symptoms of autism include severe deficits in social relatedness and communication, and interfering repetitive behavior. No medications have been shown to consistently improve any of these symptoms.

The central hypothesis of this study is that NAC will improve behavioral manifestations of autism which may include core or associated symptoms. We plan to test our hypothesis and complete the objectives of this project by pursuing the following specific aims:

  • Evaluate the efficacy of oral NAC in a 12-week, double-blind, placebo-controlled study involving 32 children and adolescents with autism spectrum disorders.
  • Evaluate the safety and tolerability of oral NAC in 32 children and adolescents with autism spectrum disorders.
  Eligibility

Ages Eligible for Study:   4 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 4 to 12 years.
  • Diagnosis of autistic disorder, Asperger's disorder, or PDD NOS.
  • If taking concomitant psychotropic medications, the medication must be at a constant dose for 60 days with no dose changes planned for the duration of the trial.
  • Able to swallow capsules.

Exclusion Criteria:

  • Presence of any medical condition that significantly increases risk or hampers assessment (e.g., unstable hypertension or cardiac disease, unstable asthma, kidney disease, unstable seizure disorder, pregnancy or any other medical condition as determined by the investigator).
  • Weight < 15 kg.
  • Subjects taking concomitant medications or supplements known for their glutamatergic effects (e.g., dextromethorphan, D-cycloserine, amantadine, memantine, lamotrigine, riluzole) or antioxidant properties (high dose vitamin supplements, DMG, TMG, many alternative treatments) within 30 days of the baseline visit with the exception of short term use of dextromethorphan as needed as a cough suppressant. The use of this medicine must be stopped at least 7 days prior to the baseline visit. Regular multivitamins will be allowed.
  • Subjects taking daily acetaminophen or nonsteroidal anti-inflammatory drugs within 30 days of the baseline visit.
  • Profound mental retardation as evidenced by a mental age below 18 months.
  • Subjects taking concomitant medications with the potential for pharmacokinetic or pharmacodynamic drug-drug interactions (e.g., carbamazepine) within 30 days of the baseline visit.
  • Subjects who are likely to experience significant changes in their ongoing psychosocial or medical treatments for autism over the course of the trial (e.g., initiation of new behavioral therapy, initiation of new medication or alternative treatment [e.g., chelation]). Minor changes in ongoing treatment (e.g., missed therapy sessions due to holiday/vacation; planned break in therapy due to school holidays) will not be considered significant.
  • History of prior treatment with NAC.
  • Evidence of hypersensitivity/allergy to NAC.
  • Presence of certain neurodevelopmental disorders such as Fragile X Syndrome, Tuberous Sclerosis, or other neurological disorders known to be associated with autism or autistic features.
  • Diagnosis of Rett's disorder, childhood disintegrative disorder, schizophrenia, bipolar disorder, another psychotic disorder, or substance abuse disorder.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453180

Locations
United States, Indiana
Riley Hospital for Children - Christian Sarkine Autism Treatment Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
National Alliance for Autism Research
Investigators
Principal Investigator: Kimberly A Stigler, M.D. Indiana University School of Medicine
  More Information

No publications provided

Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00453180     History of Changes
Other Study ID Numbers: 0611-10
Study First Received: March 27, 2007
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Asperger's Disorder
Autistic Disorder
Asperger's
PDD NOS
Pervasive Developmental Disorder
Autism
N-acetylcysteine
acetylcysteine
NAC
antioxidant
treatment
core symptoms
Autism Spectrum Disorders
Pervasive Developmental Disorder Not Otherwise Specified
Pervasive Developmental Disorders

Additional relevant MeSH terms:
Asperger Syndrome
Autistic Disorder
Developmental Disabilities
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on August 20, 2014