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

NCT03487783 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2020-12-29

No results posted yet for this study

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.

Conditions

  • Tourette Syndrome

Interventions

DRUG

Aripiprazole Oral Solution

Aripiprazole 2-20 mg/day (2-20 mL/day)

DRUG

Placebo Oral Solution

Placebo 2-20 mg/day (2-20 mL/day)

Sponsors & Collaborators

  • Otsuka Beijing Research Institute

    lead INDUSTRY

Principal Investigators

  • Patyman Juma · Otsuka Beijing Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03487783 on ClinicalTrials.gov