Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Aripiprazole in Children and Adolescents With Chronic Tic Disorder or Tourette's Disorder

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: NCT00706589
Recruitment Status : Completed
First Posted : June 27, 2008
Results First Posted : July 26, 2013
Last Update Posted : July 26, 2013
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Korea Otsuka Pharmaceutical Co., Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Chronic Motor or Vocal Tic Disorder
Tourette's Disorder
Interventions Drug: aripiprazole
Drug: placebo
Enrollment 61
Recruitment Details Recruitment period :Aug2008~Jan2010 Types of location: Medical Center
Pre-assignment Details antipsychotic or antiparkinson drugs should be washed out 1~2 weeks prior to randomization.
Arm/Group Title Aripiprazole Placebo
Hide Arm/Group Description Aripiprazole 2mg,5mg,10mg,15mg, 20mg orally administrated Once a day (Titration according to the protocol) Mode of administration: P.O Placebo 2mg,5mg,10mg,15mg, 20mg orally administrated Once a day (Titration according to the protocol)10mg,15mg, 20mg Mode of administration: P.O
Period Title: Overall Study
Started 32 29
Completed 29 25
Not Completed 3 4
Arm/Group Title Aripiprazole Placebo Total
Hide Arm/Group Description Aripiprazole 2mg,5mg,10mg,15mg Placebo 2mg,5mg,10mg,15mg Total of all reporting groups
Overall Number of Baseline Participants 32 29 61
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 29 participants 61 participants
<=18 years
32
 100.0%
29
 100.0%
61
 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 Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 29 participants 61 participants
10.97  (2.49) 10.93  (3.00) 10.95  (2.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 29 participants 61 participants
Female
2
   6.3%
6
  20.7%
8
  13.1%
Male
30
  93.8%
23
  79.3%
53
  86.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 32 participants 29 participants 61 participants
32 29 61
1.Primary Outcome
Title Mean Change of Total Tic Scores in K-YGTSS From Randomization (Baseline, Visit 2) to the Final Visit (Visit 7)
Hide Description The meaning of the total tic scores is a sum of the total motor tic score and total phonic tic score and the total tic score will be indicated from zero point to 50 points. And also, for the global tic severity scale is sum of the total tic scores and impairment score and it will be indicated from zero point to 100 points. Additionally, for the imparment score is also indicated from zero to 50 points same as total tic scores. And it is divided as 0 point, 10 point, 20 point and etc… Lastly, someone who gets a high score, it will be considered worse result.
Time Frame 10 week
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intention-To-Treat)analysis
Arm/Group Title Aripiprazole Placebo
Hide Arm/Group Description:
Aripiprazole 2mg,5mg,10mg,15mg, 20mg
Placebo 2mg,5mg,10mg,15mg, 20mg
Overall Number of Participants Analyzed 31 29
Mean (Full Range)
Unit of Measure: units on a scale
-9.62
(-32 to 8)
-14.97
(-33 to 2)
2.Secondary Outcome
Title 1)Percent Change of Total Tic Scores on the Korean Version of YaleGlobalTicseverity Scale.2)Response Rate Assessed With the Tic Score ClinicalGlobalImpressionImprovementScale.3)Mean Change in Scores on the Tic Score ClinicalGlobal ImpressionSeverityScale.
Hide Description [Not Specified]
Time Frame 10 weeks
Outcome Measure Data Not Reported
Time Frame 14 week
Adverse Event Reporting Description A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.
 
Arm/Group Title Aripiprazole Placebo
Hide Arm/Group Description Aripiprazole 2mg,5mg,10mg,15mg Placebo 2mg,5mg,10mg,15mg
All-Cause Mortality
Aripiprazole Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Aripiprazole Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/32 (0.00%)      0/28 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aripiprazole Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/32 (75.00%)      20/28 (71.43%)    
Gastrointestinal disorders     
Nausea  1  6/32 (18.75%)  6 2/28 (7.14%)  3
Dyspepsia  1  1/32 (3.13%)  1 2/28 (7.14%)  2
Vomiting  1  0/32 (0.00%)  0 3/28 (10.71%)  4
General disorders     
Irritability  1  0/32 (0.00%)  0 2/28 (7.14%)  2
Infections and infestations     
Nasopharyngitis  1  4/32 (12.50%)  4 0/28 (0.00%)  0
Upper respiratory tract infection  1  1/32 (3.13%)  1 2/28 (7.14%)  2
Investigations     
Electrocardiogram QT prolonged  1  2/32 (6.25%)  2 1/28 (3.57%)  1
Metabolism and nutrition disorders     
Anorexia  1  2/32 (6.25%)  2 1/28 (3.57%)  1
Increased appetite  1  2/32 (6.25%)  2 0/28 (0.00%)  0
Nervous system disorders     
Sedation  1  4/32 (12.50%)  5 3/28 (10.71%)  5
Akathisia  1  2/32 (6.25%)  2 4/28 (14.29%)  5
Headache  1  5/32 (15.63%)  5 1/28 (3.57%)  1
Dizziness  1  1/32 (3.13%)  1 4/28 (14.29%)  4
Extrapyramidal disorder  1  3/32 (9.38%)  3 2/28 (7.14%)  2
Somnolence  1  4/32 (12.50%)  5 0/28 (0.00%)  0
Dystonia  1  0/32 (0.00%)  0 2/28 (7.14%)  2
Psychiatric disorders     
Insomnia  1  0/32 (0.00%)  0 3/28 (10.71%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Kiho Moon
Phone: +82-2-3287-9009
EMail: khmoon@otsuka.co.kr
Layout table for additonal information
Responsible Party: Korea Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00706589     History of Changes
Other Study ID Numbers: 031-KOA-0703
First Submitted: June 25, 2008
First Posted: June 27, 2008
Results First Submitted: January 27, 2011
Results First Posted: July 26, 2013
Last Update Posted: July 26, 2013