Overview

Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Autistic Disorder

Status:
Completed
Trial end date:
2020-04-21
Target enrollment:
Participant gender:
Summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy, safety, tolerability and the steady-state plasma trough concentration of aripiprazole flexible-dosed in children and adolescents with a diagnosis of Autistic Disorder. Approximately 100 subjects will be randomly assigned at a 1:1 ratio to receive aripiprazole (2 to 15 mg) or placebo treatment for 8 weeks
Phase:
Phase 3
Details
Lead Sponsor:
Otsuka Beijing Research Institute
Treatments:
Aripiprazole
Pharmaceutical Solutions