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N-acetylcysteine (NAC) for Children With Tourette Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01172288
First Posted: July 29, 2010
Last Update Posted: February 10, 2017
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.
Collaborator:
American Academy of Child Adolescent Psychiatry.
Information provided by (Responsible Party):
Yale University
Results First Submitted: June 30, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Tourettes Syndrome
Tic
Interventions: Drug: N-Acetylcysteine (NAC)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
N-Acetylcysteine N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
Placebo Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.

Participant Flow:   Overall Study
    N-Acetylcysteine   Placebo
STARTED   17   14 
COMPLETED   16   13 
NOT COMPLETED   1   1 
Adverse Event                1                0 
Protocol Violation                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
N-Acetylcysteine N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
Placebo Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
Total Total of all reporting groups

Baseline Measures
   N-Acetylcysteine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   14   31 
Age 
[Units: Years]
Mean (Standard Deviation)
 12.4  (1.4)   11.5  (2.8)   11.9  (2.17) 
Gender 
[Units: Participants]
Count of Participants
     
Female      5  29.4%      2  14.3%      7  22.6% 
Male      12  70.6%      12  85.7%      24  77.4% 
Age of onset 
[Units: Years]
Mean (Standard Deviation)
 6.8  (1.4)   6.1  (2.4)   6.4  (1.17) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Improvement in Tic Severity   [ Time Frame: 12 weeks ]

2.  Secondary:   Improvement of Premonitory Urges   [ Time Frame: 12 weeks ]

3.  Secondary:   Improvement in OCD Severity   [ Time Frame: 12 weeks ]

4.  Secondary:   Overall Improvement   [ Time Frame: 12 weeks ]

5.  Secondary:   Number of Participants With Adverse Effects   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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: Associate Professor
Organization: Yale University- School of Medicine
phone: (203)737-4809
e-mail: michael.bloch@yale.edu


Publications of Results:
Other Publications:

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01172288     History of Changes
Other Study ID Numbers: YCSC1004006637
First Submitted: July 27, 2010
First Posted: July 29, 2010
Results First Submitted: June 30, 2016
Results First Posted: December 19, 2016
Last Update Posted: February 10, 2017