At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 133 enrolled
Drug / intervention
Aripiprazole +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Nov 16, 2012·Updated Feb 13, 2015
In Brief
A Phase 3 clinical trial evaluating Aripiprazole and Placebo for Tourette's Disorder and Tic Disorder. Completed, enrolled 133 participants across 75 sites in 9 countries.
Detailed Summary
The goal of the current trial is to determine efficacy and safety of Once-daily aripiprazole in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTourette's Disorder, Tic Disorder
CountriesCanada, Germany, Hungary, Italy, Mexico, Romania, Spain, Sweden, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2012
First PostedNov 2012
Primary CompletionAug 2013
Study CompletionSep 2013
TodayJul 2026
First PostedNov 16, 2012
Enrollment StartNov 1, 2012
Primary CompletionAug 1, 2013
Study CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 13.6 years ago
Interventions
Aripiprazoledrug
Once-daily, tablet
Placebodrug