drugset / Trial / NCT03487783
Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Tourette's Syndrome
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |