At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 83 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-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 83 participants across 35 sites in 5 countries.
Detailed Summary
The goal of the current trial 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
CountriesBulgaria, Germany, Romania, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2011
First PostedAug 2011
Primary CompletionMar 2014
TodayJul 2026
First PostedAug 17, 2011
Enrollment StartAug 2, 2011
Primary CompletionMar 12, 2014
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 14.9 years ago
Interventions
Aripiprazoledrug
Aripiprazole tablets once weekly for 8 weeks.
Placebodrug
Aripiprazole matching-placebo once-weekly for 8 weeks.