NCT03487783

Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Tourette's Syndrome

A Multicenter, Randomized, Double-Blind, Flexible-Dosed, Placebo-Controlled, Parallel-Group Clinical Trial Evaluating the Efficacy and Safety of Aripiprazole Oral Solution in Children and Adolescents With Tourette's Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Otsuka Beijing Research Institute · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, double-blind, placebo-controlled trial designed to assess the safety, efficacy, tolerability and steady-state plasma trough concentration of flexible-dosed aripiprazole once-daily administration in children and adolescents with Tourette's syndrome. A total of around 120 subjects will be randomized to aripiprazole (2\~20 mg) or placebo in a 1:1 ratio (approximately 60 subjects in each group), for treatment of 8 weeks.

Detailed description

Screening phase: It can last up to 42 days, including the screening visit (V1), a washout period when applicable, additional screening visit (V1a) and baseline visit (V2). The screening phase will serve the following purposes: 1) To allow for appropriate washout of prohibited medications; 2) To review the screening data; 3) To establish a pretreatment baseline of critical outcome measures. Treatment phase: It lasts 8 weeks; the purpose of the treatment phase is to assess the efficacy, safety, tolerability and steady-state plasma trough concentration of aripiprazole in the treatment of children and adolescents with Tourette's syndrome. Safety follow-up phase: All subjects will be followed up for safety (adverse events) at Day 16 after the final medication via telephone

Conditions

• Tourette Syndrome

Interventions

Type	Name	Description
DRUG	Aripiprazole Oral Solution	Aripiprazole 2-20 mg/day (2-20 mL/day)
DRUG	Placebo Oral Solution	Placebo 2-20 mg/day (2-20 mL/day)

Timeline

• Start date: 2018-05-02
• Primary completion: 2020-02-14
• Completion: 2020-02-14
• First posted: 2018-04-04
• Last updated: 2020-12-29

Locations

1 site across 1 country: China