Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
|ClinicalTrials.gov Identifier: NCT01727700|
Recruitment Status : Completed
First Posted : November 16, 2012
Results First Posted : February 13, 2015
Last Update Posted : February 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Tourette's Disorder Tic Disorder||Drug: Aripiprazole Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||133 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Fixed-Dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder|
|Study Start Date :||November 2012|
|Primary Completion Date :||August 2013|
|Study Completion Date :||September 2013|
Placebo Comparator: Placebo
Matching Placebo Once-Daily
Experimental: Aripiprazole 5 mg or 10 mg
Aripiprazole 5 mg or 10 mg Immediate Release Once-Daily
Other Name: Abilify
Experimental: Aripiprazole 10 mg or 20 mg
Aripiprazole 10 mg 20 mg Immediate Release Once-Daily
Other Name: Abilify
- Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS). [ Time Frame: Baseline to Week 8 ]The YGTSS is a semi-structured clinical interview designed to measure current (time frame of the past 1 week) tic severity. This scale consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings are made along 5 different dimensions on a scale of 0 to 5 for motor and vocal tics each, including number, frequency, intensity, complexity, and interference. Summation of these 10 scores (ie, 0-50) provides a TTS that was the primary outcome measure in this trial. The YGTSS ranking of impairment score rated on a 50-point scale anchored from 0 (no impairment) to 50 (severe impairment) to assess impairment experienced in areas of self-esteem, family life, social acceptance, and school scores. This is a fully validated scale in adults and has become a standard instrument for the evaluation of the severity of TD in children.
- Change in Clinical Global Impressions Scale-Tourette's Syndrome (CGI-TS) Score at Week 8. [ Time Frame: Week 8 ]To assess CGI-TS severity, the rater or physician answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" However, the evaluation of illness was limited to manifestations of TD only. Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The change score was obtained from CGI-TS improvement scale assessment: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
- Mean Change From Baseline to Endpoint (Week 8) in Total YGTSS Score [ Time Frame: Baseline to Week 8 ]The YGTSS consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms (on a scale of 0 to 5 for 5 different dimensions, including number, frequency, intensity, complexity, and interference) of motor and vocal tics, and an impairment ranking. The Total YGTSS score is the summation of the severity scores of motor and vocal tics and also the ranking of impairment (range of 0 to 100). A missing value of a YGTSS item scale could result in a missing Total YGTSS score. A reduction in Total YGTSS score from baseline represents an improvement in symptoms.
- Mean Change From Baseline to Endpoint (Week 8) in CGI-TS Severity Score [ Time Frame: Baseline to Week 8 ]The CGI-TS Severity scale (range 0-7) is a single-item rating score, with higher scores representing greater severity or less improvement. A response of 0 (not assessed) is considered and handled as missing data.
- Response Rate [ Time Frame: Week 8 ]Clinical response is defined as > 25% improvement from baseline to Week 8 in YGTSS TTS or a CGI-TS Change score of 1 [very much improved] or 2 [much improved] at Week 8. Response will be considered as missing only if both YGTSS TTS and CGI-TS change score are missing. As long as one of them is non-missing, response outcome will be determined based on the non-missing score.
- Treatment Discontinuation Rate [ Time Frame: Week 8 ]Treatment discontinuation rate will be calculated as the number of discontinued participants (ie, those who were withdrawn from the trial without completing the Week 8 visit) over the number of all randomized participants.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727700
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|Study Director:||Eva Kohegyi, MD||Otsuka Pharmaceutical Development & Commercialization, Inc.|