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Trial record 88 of 648 for:    NAC

An Open-Label Study of N-Acetyl Cysteine in Children With Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00676195
Recruitment Status : Completed
First Posted : May 12, 2008
Results First Posted : March 29, 2017
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
Antonio Hardan, Stanford University

Tracking Information
First Submitted Date  ICMJE May 7, 2008
First Posted Date  ICMJE May 12, 2008
Results First Submitted Date  ICMJE August 12, 2016
Results First Posted Date  ICMJE March 29, 2017
Last Update Posted Date March 29, 2017
Study Start Date  ICMJE June 2008
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2017)
Number of Participants With Adverse Events Reported on the Dosage Record and Treatment Emergent Symptom Scale (DOTES) [ Time Frame: 4, 8, and 12 weeks ]
Number of Participants with adverse events reported on the Dosage Record and Treatment Emergent Symptom Scale (DOTES) during the course of the study as measured at time points (4, 8, and 12 weeks).
Original Primary Outcome Measures  ICMJE
 (submitted: May 9, 2008)
  • Dosage Record and Treatment Emergent Symptom Scale (DOTES)
  • The Clinical Global Rating Scale (CGRS) Improvement subscale
  • GSH levels in peripheral blood, measured by state-of-the-art high-performance liquid chromatography (HPLC)
  • The Aberrant Behavior Checklist total score (ABC)
Change History Complete list of historical versions of study NCT00676195 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2017)
  • Social Responsiveness Scale (SRS) [ Time Frame: 12 weeks ]
  • Sensory Profile Questionnaire (SPQ) [ Time Frame: 12 weeks ]
  • Irritability Subscale of the Aberrant Behavior Checklist (ABC) [ Time Frame: 4, 8, and 12 weeks ]
  • Glutathione Metabolism Intermediates in Peripheral Blood Measured by High-performance Liquid Chromatography [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2008)
  • Social Responsiveness Scale (SRS)
  • Sensory Profile Questionnaire (SPQ)
  • The Irritability subscale of the ABC
  • Yale-Brown Obsessive Compulsive scale (Y-BOCS)
  • GSH metabolism intermediates in peripheral blood measured by HPLC
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-Label Study of N-Acetyl Cysteine in Children With Autism
Official Title  ICMJE An Open-Label Study of N-Acetyl Cysteine in Autism
Brief Summary The purpose of the study is to test the tolerability and efficacy of N-Acetyl Cysteine (NAC) in children with Autism.
Detailed Description N-Acetyl Cysteine (NAC) is a compound that increases the levels of Glutathione, the body's main antioxidant. Glutathione is a compound in the blood that is part of a natural defense system (the antioxidant system). Anti-oxidants protect the body from damage caused by internal toxins called free radicals. It is possible that children with Autism tend to have lower levels of glutathione, an important compound in our bodies that helps combat the effects of toxic free radicals. We hope that by studying the antioxidant system in more detail, we will increase our understanding of the reasons why people develop Autism so that we can design better ways to treat individuals with this condition. This study is meant to test the safety tolerability of N-Acetyl Cysteine and its effectiveness in the treatment of behavioral difficulties in children with autism. It will also examine the possible benefit of this agent in improving the core deficits in autism such as social deficits.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Autistic Disorder
Intervention  ICMJE Drug: N-Acetyl Cysteine

Dosage of orally administered N-Acetyl Cysteine is as follows:

Days 1-30: 900 mg, once per day Days 31-60: 900 mg, twice per day Days 61-90: 900 mg, three times per day

Other Name: NAC
Study Arms  ICMJE Experimental: N-Acetyl Cysteine

Dosage of orally administered N-Acetyl Cysteine is as follows:

Days 1-30: 900 mg, once per day Days 31-60: 900 mg, twice per day Days 61-90: 900 mg, three times per day

Intervention: Drug: N-Acetyl Cysteine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 13, 2012)
24
Original Enrollment  ICMJE
 (submitted: May 9, 2008)
40
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects will be eligible for this study if they participated in the Double-blind, randomized, placebo controlled study of N-Acetyl Cysteine in Autism study at Stanford University and meet all of the following criteria:

  1. Outpatients between 3.0 and 12.11 years of age inclusive
  2. Males and females who are physically healthy
  3. diagnosis of autism based on Diagnostic and Statistical Manual (DSM-IV-TR) criteria, the Autism Diagnostic Interview-Revised, and expert clinical evaluation
  4. Clinical Global Impression Severity rating of 4
  5. Care provider who can reliably bring subject to clinic visits, can provide trustworthy ratings, and interacts with subject on a regular basis
  6. Ability of subject to swallow the compound
  7. Stable concomitant medications for at least 2 weeks
  8. No planned changes in psychosocial interventions during the open-label N-Acetyl Cysteine trial

Exclusion Criteria:

  1. Diagnostic and Statistical Manual (DSM-IV-TR) diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder, not otherwise specified
  2. Active medical problems: unstable seizures, significant physical illness (e.g., serious liver or renal pathology)
  3. Pregnancy or sexually active females
  4. Subjects taking antioxidant agents and glutathione prodrugs will be excluded from the study except if they have been off these compounds for at least 4 weeks
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00676195
Other Study ID Numbers  ICMJE SU-05062008-1139
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Antonio Hardan, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Antonio Hardan, MD Stanford University
PRS Account Stanford University
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP