ABF Tourette's Disorder Post Marketing Surveillance Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

692 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-05-29

Brief Summary

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This is a Post-Marketing Surveillance study of Abilify® tablets in accordance with Korean regulations on New Drug Re-examination (i.e. New Drug Re-examination Standards: KFDA Notification No. 2010-94 dated 27 December 2010).

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Detailed Description

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This study will be conducted in a prospective, single-arm, multi-center format. As this study is observational in nature, the patient's follow-up is not prescriptive in nature and must be left up to the judgment of the physician (investigator), within the period of observation set forth in the protocol.

Conditions

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Tourette's Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Aripiprazole (Abilify® Tablets/Abilify® ODT)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Pediatric patients 6 to 18 years of age with Tourette's Disorder
* Patients who are prescribed Abilify® treatment as per investigator's medical judgment.
* Patients who gave written authorization to use their personal and health data
* Patients starting Abilify® treatment after agreement is in place

Exclusion Criteria

* Patients with known hypersensitivity to Aripiprazole or any excipients of Abilify®
* Patients who have been treated with Abilify®
* Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency, or glucose-galactose malabsorption
* Patients with score 0(Not assessed) or 1(Normal, not at all ill) in the TS-CGI-S
* Patients participating in other clinical trial

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No