Status:
COMPLETED
ABF Tourette's Disorder Post Marketing Surveillance Study
Lead Sponsor:
Korea Otsuka Pharmaceutical Co., Ltd.
Conditions:
Tourette's Disorder
Eligibility:
All Genders
6-18 years
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 ...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 29 2015
Estimated Enrollment :
692 Patients enrolled
Trial Details
Trial ID
NCT01795105
Start Date
June 1 2012
End Date
May 29 2015
Last Update
April 1 2019
Active Locations (4)
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1
Inha University Hospital
Incheon, South Korea
2
Chonbuk National University Hospital
Jeonju, South Korea, 561-712
3
Seoul National University Hospital
Seoul, South Korea, 110-744
4
Seoul Medical Center
Seoul, South Korea, 131-795