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Safety and Tolerability Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

NCT01416441 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2021-10-07

Study results available
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Summary

The goal of the current trial is to obtain long term efficacy, safety and tolerability data of once weekly aripiprazole in children and adolescents with Tourette's Disorder.

Conditions

  • Tourette's Disorder

Interventions

DRUG

Aripiprazole

Aripiprazole tablets orally once daily.

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Principal Investigators

  • Eva Kohegyi, MD · Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-19
Primary Completion
2014-03-13
Completion
2014-03-13
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Canada
  • Germany
  • Hungary
  • Mexico
  • Romania
  • South Korea
  • Taiwan
  • Ukraine

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 NCT01416441 on ClinicalTrials.gov