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Trial record 88 of 639 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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Autistic Disorder
Intervention Drug: N-Acetyl Cysteine
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title N-Acetyl Cysteine
Hide Arm/Group Description

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

Period Title: Overall Study
Started 24
Completed 21
Not Completed 3
Reason Not Completed
Lost to Follow-up             1
Adverse Event             1
Physician Decision             1
Arm/Group Title N-Acetyl Cysteine
Hide Arm/Group Description

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

Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
<=18 years
24
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
2
   8.3%
Male
22
  91.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants
24
1.Primary Outcome
Title Number of Participants With Adverse Events Reported on the Dosage Record and Treatment Emergent Symptom Scale (DOTES)
Hide Description 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).
Time Frame 4, 8, and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title N-Acetyl Cysteine
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: number of participants
17
2.Secondary Outcome
Title Social Responsiveness Scale (SRS)
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses were conducted since it is an open-label trial and data was analyzed in the double-blind phase. Additionally, the main reason for the this phase is to allow participants who were on the placebo during the double-blind phase of NCT00627705 to receive the compound.
Arm/Group Title Open-Label
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Sensory Profile Questionnaire (SPQ)
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses were conducted since it is an open-label trial and data was analyzed in the double-blind phase. Additionally, the main reason for the this phase is to allow participants who were on the placebo during the double-blind phase of NCT00627705 to receive the compound.
Arm/Group Title Open-Label
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Irritability Subscale of the Aberrant Behavior Checklist (ABC)
Hide Description [Not Specified]
Time Frame 4, 8, and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses were conducted since it is an open-label trial and data was analyzed in the double-blind phase. Additionally, the main reason for the this phase is to allow participants who were on the placebo during the double-blind phase of NCT00627705 to receive the compound.
Arm/Group Title Open-Label
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Glutathione Metabolism Intermediates in Peripheral Blood Measured by High-performance Liquid Chromatography
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No analyses were conducted since it is an open-label trial and data was analyzed in the double-blind phase. Additionally, the main reason for the this phase is to allow participants who were on the placebo during the double-blind phase of NCT00627705 to receive the compound.
Arm/Group Title Open-Label
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Baseline and 4, 8 and 12 Weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title N-Acetyl Cysteine
Hide Arm/Group Description

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

All-Cause Mortality
N-Acetyl Cysteine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
N-Acetyl Cysteine
Affected / at Risk (%) # Events
Total   0/24 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
N-Acetyl Cysteine
Affected / at Risk (%) # Events
Total   19/24 (79.17%)    
Gastrointestinal disorders   
Nausea/Vomiting   2/24 (8.33%)  3
Diarrhea   3/24 (12.50%)  3
Decreased Appetite   5/24 (20.83%)  6
General disorders   
Nasal Congestion   6/24 (25.00%)  6
Insomnia   4/24 (16.67%)  4
Decreased Motor Activity   2/24 (8.33%)  2
Grinding Teeth *  2/24 (8.33%)  2
Psychiatric disorders   
Depressive Affect   3/24 (12.50%)  3
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
This is an open-label trial with a small sample size.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Antonio Hardan, MD
Organization: Stanford University School of Medicine
Phone: 650-736-1235
Responsible Party: Antonio Hardan, Stanford University
ClinicalTrials.gov Identifier: NCT00676195     History of Changes
Other Study ID Numbers: SU-05062008-1139
First Submitted: May 7, 2008
First Posted: May 12, 2008
Results First Submitted: August 12, 2016
Results First Posted: March 29, 2017
Last Update Posted: March 29, 2017