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

Tourette Syndrome Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome

• NCT number: NCT03487783
• Study type: Interventional
• Source: Otsuka Beijing Research Institute
• Status: Completed
• Phase: Phase 3
• Start date: May 2, 2018
• Completion date: February 14, 2020