ABF Tourette's Disorder Post Marketing Surveillance Study

Completed

• Conditions: Tourette's Disorder

• Registration Number: NCT01795105
• Lead Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

Brief Summary

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).

Detailed Description

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-01-31
• Study First Submitted QC: 2013-02-17
• Study First Posted: 2013-02-20
• Primary Completion: 2015-05-29
• Study Completion: 2015-05-29
• Status Verified: 2018-01
• Results First Submitted: 2018-01-14
• Results First Submitted QC: 2019-01-04
• Last Update Submitted: 2019-01-04
• Results First Posted: 2019-04-01
• Last Update Posted: 2019-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 692

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency (n) of Subjects With Adverse Event	Follow-up at least once from baseline to 6 weeks and at least 12weeks	Frequency (n) and Percentage(%) of subjects with Adverse event

Secondary Outcome Measures

Name	Time	Method
Mean Change in the TS-CGI(Tourette's Syndrome-Clinical Global Impression-Improvement)	at least 6, 12 weeks interval from baseline	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

Trial Locations

Locations (4)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of

Chonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of

Seoul Medical Center; 🇰🇷 Seoul, Korea, Republic of