At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 110 enrolled
Drug / intervention
Aripiprazoledrug
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.
An Open-Label, Multicenter Study Evaluating the Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Nov 16, 2012·Updated Oct 16, 2015
In Brief
A Phase 3 clinical trial evaluating Aripiprazole for Tourette's Disorder and Tic Disorder. Completed, enrolled 110 participants across 33 sites in 4 countries.
Detailed Summary
The goal of the current trial is to determine 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, Hungary, Italy, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 2012
Enrollment StartJan 2013
Primary CompletionAug 2014
Study CompletionSep 2014
TodayJul 2026
First PostedNov 16, 2012
Enrollment StartJan 1, 2013
Primary CompletionAug 1, 2014
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 13.6 years ago
Interventions
Aripiprazoledrug
Open Label: Once-Daily formulation of aripiprazole flex dose regimine