Trials / Completed
CompletedNCT01418352
Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder (TD)
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 83 (actual)
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
- Sex
- All
- Age
- 7 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aripiprazole | Aripiprazole tablets once weekly for 8 weeks. |
| DRUG | Placebo | Aripiprazole matching-placebo once-weekly for 8 weeks. |
Timeline
- Start date
- 2011-08-02
- Primary completion
- 2014-03-12
- Completion
- 2014-03-12
- First posted
- 2011-08-17
- Last updated
- 2021-10-07
- Results posted
- 2021-10-07
Locations
35 sites across 5 countries: United States, Bulgaria, Germany, Romania, Ukraine
Source: ClinicalTrials.gov record NCT01418352. Inclusion in this directory is not an endorsement.