drugset / Trial / NCT03487783

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

NCT03487783

Phase 3 Completed 121 enrolled Otsuka Beijing Research Institute
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2018-05-02
Primary completion
2020-02-14
Completion
2020-02-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Aripiprazole Other / unclassified 2 mg Oral
Subject Aripiprazole Other / unclassified 5 mg Oral
Subject Aripiprazole Other / unclassified 10 mg Oral
Subject Aripiprazole Other / unclassified 15 mg Oral
Subject Aripiprazole Other / unclassified 20 mg Oral

Indications