ABF Tourette's Disorder Post Marketing Surveillance Study

Korea Otsuka Pharmaceutical Co., Ltd.692 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

692

Conditions

Tourette's Disorder

Eligibility

Sex: ALLMin age: 6 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Inha University Hospital

Incheon, South Korea

Chonbuk National University Hospital

Jeonju, South Korea

Seoul National University Hospital

Seoul, South Korea

Seoul Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Frequency (n) of Subjects With Adverse Event

Frequency (n) and Percentage(%) of subjects with Adverse event

Time frame: Follow-up at least once from baseline to 6 weeks and at least 12weeks

Secondary Outcomes

Mean Change in the TS-CGI(Tourette's Syndrome-Clinical Global Impression-Improvement)

Mean change in the TS-CGI from baseline to next visit(at least 6, 12 weeks interval from baseline) post-treatment \*TS-CGI scale 0=Not assessed 1. Normal, not at all ill 2. Borderline ill 3. Mildly ill 4. Moderately ill 5. Markedly ill 6. Severely ill 7. Extremely ill

Time frame: at least 6, 12 weeks interval from baseline

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.