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Open Label Trial of Aripiprazole in Children and Adolescents With Tourette's Disorder

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ClinicalTrials.gov Identifier: NCT00241176
Recruitment Status : Completed
First Posted : October 18, 2005
Results First Posted : January 25, 2013
Last Update Posted : December 9, 2016
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Tourette's Syndrome
Tic Disorders
Intervention Drug: Aripiprazole
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aripiprazole
Hide Arm/Group Description Subjects received initial dose based on body weight at Visit 2: Subjects between 25-50 kg were started on 1.25 mg/day, Subjects between 50-70 kg were started on 2.5 mg/day, Subjects greater than 70 kg were started on 5 mg/day. Dosage was titrated at Visit 3, 5, 6, or 7 based on YGTSS and CGI-TS ratings at the discretion of the investigator. Subjects who showed evidence of response (reduction in CGI-TS by 1-2 points)remained on the same dose. Subjects who did not show evidence of response could be increased: Subjects between 25-50 kg were could be increased 1.25 mg/day at each titration visit, Subjects between 50-70 kg could be increased 2.5 mg/day at each titration visit, and Subjects greater than 70 kg could be increased 5 mg/day at each titration visit.
Period Title: Overall Study
Started 11
Completed 11
Not Completed 0
Arm/Group Title Sample
Hide Arm/Group Description Sample of children and adolescents that enrolled in study to receive active medication. This was not a placebo controlled study.
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
10
  90.9%
Between 18 and 65 years
1
   9.1%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
13.36  (3.33)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
1
   9.1%
Male
10
  90.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Calculating Difference Between Means (Baseline and Endpoint Scores on the Yale Global Tic Severity Scale Subscales)
Hide Description The Yale Global Tic Severity Scale (YGTSS) is a clinical rating instrument that was designed for use in studies of Tourette's syndrome and other tic disorders. The YGTSS provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic symptoms. The maximum YGTSS Global score is 100, while the maximum motor score is 25, the maximum vocal score is 25, and the maximum impairment score is 50. Higher scores indicate more severe tics.
Time Frame 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 - Baseline Group 1 - Endpoint
Hide Arm/Group Description:
Sample of children and adolescents that enrolled in study to receive active medication at baseline.
Sample of children and adolescents that enrolled in study to receive active medication at endpoint prior to down titration.
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
YGTSS Motor Tic 15.82  (4.40) 9.73  (2.76)
YGTSS Vocal Tic 12.36  (7.10) 7.00  (5.76)
YGTSS Total Tic 28.18  (7.74) 16.73  (7.54)
YGTSS Global Severity 61.82  (13.49) 33.73  (15.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 - Baseline, Group 1 - Endpoint
Comments Group 1 Baseline vs. Endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .003
Estimation Comments YGTSS Global Severity score (M=61.8 SD=13.49) declined significantly to end point (M=33.7 SD=15.18; p=0.003).
2.Secondary Outcome
Title Clinical Global Impression Severity Scores
Hide Description The Clinical Global Impression scale (CGI) is a classic instrument for making global assessments. This scale yields three different measures: 1. Severity of illness (7-point scale, with 7 being the most impaired; assessment of patient's current symptom severity, referred to here as CGIs), 2. Global improvement (7-point scale, with 7 being the most impaired; comparison of patient's baseline condition with his/her current condition, referred to here as CGIi), 3. Efficacy index (4 point x 4 point rating scale, comparison of patient's baseline condition with a ratio of current therapeutic benefit to severity of side effects)
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 - Baseline Group 1 - Endpoint
Hide Arm/Group Description:
Sample of children and adolescents that enrolled in study to receive active medication at baseline.
Sample of children and adolescents that enrolled in study to receive active medication at endpoint prior to down titration.
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.45  (0.52) 3.18  (0.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 - Baseline, Group 1 - Endpoint
Comments Mean scores baseline to endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .004
Estimation Comments Mean (SD) CGI-Tic severity scores reduced significantly from (M=4.45 SD=0.52) (moderate-marked) at baseline to (M=3.18 SD =0.60) (mild) at end point ( p=0.004).
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sample
Hide Arm/Group Description Sample of children and adolescents that enrolled in study to receive active medication. This was not a placebo controlled study.
All-Cause Mortality
Sample
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sample
Affected / at Risk (%) # Events
Total   0/11 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sample
Affected / at Risk (%) # Events
Total   11/11 (100.00%)    
Gastrointestinal disorders   
Stomach discomfort   9/11 (81.82%)  26
General disorders   
Headache   11/11 (100.00%)  34
Appetite increase/weight gain   7/11 (63.64%)  27
Tiredness/fatigue   8/11 (72.73%)  23
Dizziness   9/11 (81.82%)  18
Appetite decrease/weight loss   6/11 (54.55%)  12
Drowsiness/sedation   7/11 (63.64%)  13
Dry mouth   4/11 (36.36%)  10
Musculoskeletal and connective tissue disorders   
Muscle, bone, or joint pain condition   10/11 (90.91%)  31
Indicates events were collected by systematic assessment
All subjects failed to respond to previous tic medications so could have unique tic symptoms, small sample size, and this was an open-label study, so we did not have a comparison group nor were we blinded to treatment.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Barbara J Coffey, M.D, M.S.
Organization: NYU School of Medicine, NYU Child Study Center
Phone: (212)263-3926
EMail: barbara.coffey@mssm.edu
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT00241176     History of Changes
Other Study ID Numbers: H12189
First Submitted: October 14, 2005
First Posted: October 18, 2005
Results First Submitted: June 7, 2012
Results First Posted: January 25, 2013
Last Update Posted: December 9, 2016