ABF Tourette's Disorder Post Marketing Surveillance Study
Post-Marketing Surveillance of Safety and Efficacy of Abilify® Tablets in Korean Patients With Tourette's Disorder Under the "New Drug Re-Examination"
1 other identifier
observational
692
1 country
4
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2012
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 31, 2013
CompletedFirst Posted
Study publicly available on registry
February 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2015
CompletedResults Posted
Study results publicly available
April 1, 2019
CompletedApril 1, 2019
January 1, 2018
3 years
January 31, 2013
January 14, 2018
January 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency (n) of Subjects With Adverse Event
Frequency (n) and Percentage(%) of subjects with Adverse event
Follow-up at least once from baseline to 6 weeks and at least 12weeks
Secondary Outcomes (1)
Mean Change in the TS-CGI(Tourette's Syndrome-Clinical Global Impression-Improvement)
at least 6, 12 weeks interval from baseline
Study Arms (1)
Aripiprazole (Abilify® Tablets/Abilify® ODT)
Eligibility Criteria
Pediatric patients 6 to 18 years of age with Tourette's Disorder according to the approved product market authorization
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Inha University Hospital
Incheon, South Korea
Chonbuk National University Hospital
Jeonju, 561-712, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Seoul Medical Center
Seoul, 131-795, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jeong, Hyo-Won
- Organization
- KoreaOtsukaPharma
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2013
First Posted
February 20, 2013
Study Start
June 1, 2012
Primary Completion
May 29, 2015
Study Completion
May 29, 2015
Last Updated
April 1, 2019
Results First Posted
April 1, 2019
Record last verified: 2018-01