NCT03661983

Trial to Evaluate the Long-term Efficacy of Oral Aripiprazole in the Treatment of Pediatric Participants With Tourette's Disorder

A Randomized, Placebo-controlled Trial to Evaluate the Long-term (ie, Maintenance) Efficacy of Oral Aripiprazole in the Treatment of Pediatric Subjects With Tourette's Disorder

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the long-term efficacy of oral aripiprazole in pediatric participants for the treatment of Tourette's Disorder (TD).

Detailed description

This study will evaluate the long-term efficacy of oral aripiprazole in the treatment of pediatric participants with Tourette's Disorder (TD). The trial consists of 3 distinct phases: a pretreatment phase, open-label stabilization phase, and a double-blind randomized withdrawal phase.

Conditions

• Tourette's Disorder (TD)

Interventions

Type	Name	Description
DRUG	Aripiprazole	Participants received aripiprazole tablets, orally as per the regimen specified in the arm description.
DRUG	Placebo	Participants received aripiprazole matching-placebo tablets, orally as per the regimen specified in the arm description.

Timeline

• Start date: 2018-10-13
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2018-09-07
• Last updated: 2021-03-09
• Results posted: 2021-01-22

Locations

42 sites across 3 countries: United States, Canada, Hungary

Regulatory

• FDA-regulated drug study