At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 135 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 Flexible-Dose Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Aug 17, 2011·Updated Oct 7, 2021
In Brief
A Phase 3 clinical trial evaluating Aripiprazole and Placebo for Tourette's Disorder. Completed, enrolled 135 participants across 39 sites in 6 countries.
Detailed Summary
The goal of the current study is to determine efficacy and safety of once-weekly aripiprazole in reducing Total Tic Severity (TTS) score in children and adolescents with Tourette's Disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTourette's Disorder
CountriesCanada, Hungary, Mexico, South Korea, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2011
First PostedAug 2011
Primary CompletionNov 2013
TodayJul 2026
First PostedAug 17, 2011
Enrollment StartJul 27, 2011
Primary CompletionNov 6, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.9 years ago
Interventions
Aripiprazoledrug
Aripiprazole tablet administered orally once a week.
Placebodrug
Aripiprazole-matching placebo tablet administered orally once a week.