A 52-Week, Open-label, Multicenter Study of the Safety and Tolerabilityof Aripiprazole Flexibly Dosed in the Treatment of Children andAdolescents with Autistic Disorder

Phase 1

Conditions: Autistic disorder
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2017-000175-86-Outside-EU/EEA

Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization,

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 330

Inclusion Criteria

This was an open-label, multicenter safety investigation of aripiprazole,
flexibly dosed, in children and adolescents with a diagnosis of AD.
Subjects who
completed either of the antecedent double-blind, parallel-group studies
of aripiprazole in
comparison to placebo (protocols CN138178 or CN138179) were
eligible to enter this
52-week trial, provided that continuation of treatment was clinically
warranted, as judged
by the investigator, and there were no clinically relevant AEs that
would preclude
inclusion in the trial.
Are the trial subjects under 18? yes
Number of subjects for this age range: 330
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Adverse Events
Non-participation in Parent Studies

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this trial was to evaluate long-term safety and<br>tolerability of<br>aripiprazole flexibly dosed in the treatment of serious behavioral<br>problems in children<br>and adolescents with a diagnosis of autistic disorder.;Secondary Objective: To evaluate efficacy using the Aberrant Behavior Checklist (ABC) and<br>Clinical<br>Global Impression of Severity (CGI-S)<br>To evaluate the long-term effect of aripiprazole flexibly dosed on<br>health-related<br>quality of life in children and adolescents with a diagnosis of autistic<br>disorder, as<br>measured by the Pediatric Quality of Life (PedsQL) 4.0;Primary end point(s): ABC, Clinical Global Impression-Improvement (CGI-I), CGI-S, and<br>Children's<br>Yale-Brown Obsessive Compulsive Scale (CY-BOCS).;Timepoint(s) of evaluation of this end point: 52 Weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): AEs, physical examinations, vital signs, body weight/BMI, ECGs,<br>clinical<br>laboratory evaluations, and extrapyramidal symptom (EPS) measures<br>including the<br>AIMS, Barnes Akathisia Scale, and SAS.;Timepoint(s) of evaluation of this end point: 52 Weeks