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Trial record 21 of 72 for:    "Asperger syndrome"

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

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ClinicalTrials.gov Identifier: NCT00453180
Recruitment Status : Completed
First Posted : March 28, 2007
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
National Alliance for Autism Research
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Autistic Disorder
Asperger Syndrome
Child Development Disorders, Pervasive
Interventions: Drug: N-acetylcysteine
Drug: Placebo

  Participant Flow

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
No text entered.

Reporting Groups
  Description
N-acetylcysteine

Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.

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.

Placebo

Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.

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


Participant Flow:   Overall Study
    N-acetylcysteine   Placebo
STARTED   16   15 
COMPLETED   13   12 
NOT COMPLETED   3   3 
Lost to Follow-up                2                1 
Adverse Event                1                2 



  Baseline Characteristics

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

Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.

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.

Placebo

Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.

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

Total Total of all reporting groups

Baseline Measures
   N-acetylcysteine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   15   31 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      16 100.0%      15 100.0%      31 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 7.6  (2.5)   8.2  (2.9)   7.8  (2.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  25.0%      3  20.0%      7  22.6% 
Male      12  75.0%      12  80.0%      24  77.4% 
Region of Enrollment 
[Units: Participants]
     
United States   16   15   31 
Clinical Global Impression-Severity [1] 
[Units: Participants]
Count of Participants
     
1. Normal, not al all ill      0   0.0%      0   0.0%      0   0.0% 
2. Borderline ill      0   0.0%      0   0.0%      0   0.0% 
3..Mildly ill      0   0.0%      0   0.0%      0   0.0% 
4. Moderatly ill      6  37.5%      9  60.0%      15  48.4% 
5. Markedly ill      9  56.3%      6  40.0%      15  48.4% 
6. Severly ill      1   6.3%      0   0.0%      1   3.2% 
7. Extremly ill      0   0.0%      0   0.0%      0   0.0% 
[1] The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.


  Outcome Measures

1.  Primary:   Clinical Global Impression - Severity   [ Time Frame: Week 12 ]

2.  Primary:   Clinical Global Impression - Improvement   [ Time Frame: Week 12 ]

3.  Secondary:   Aberrant Behavior Checklist   [ Time Frame: Week 12 ]

4.  Secondary:   Social Responsiveness Scale   [ Time Frame: Week 12 ]

5.  Secondary:   Pervasive Developmental Disorder Behavior Index   [ Time Frame: Week 12 ]

6.  Secondary:   Vineland Adaptive Behavior Scales-II (VABS-II)   [ Time Frame: Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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: Craig Erickson
Organization: Cincinnati Childrens Hospital
phone: 513-636-6258
e-mail: craig.erickson@cchmc.org


Publications:

Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00453180     History of Changes
Other Study ID Numbers: 0611-10
First Submitted: March 27, 2007
First Posted: March 28, 2007
Results First Submitted: March 29, 2017
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017