NCT01795105
Completed
Not Applicable
Post-Marketing Surveillance of Safety and Efficacy of Abilify® Tablets in Korean Patients With Tourette's Disorder Under the "New Drug Re-Examination"
ConditionsTourette's Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tourette's Disorder
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Enrollment
- 692
- Locations
- 4
- Primary Endpoint
- Frequency (n) of Subjects With Adverse Event
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Frequency (n) of Subjects With Adverse Event
Time Frame: Follow-up at least once from baseline to 6 weeks and at least 12weeks
Frequency (n) and Percentage(%) of subjects with Adverse event
Secondary Outcomes
- Mean Change in the TS-CGI(Tourette's Syndrome-Clinical Global Impression-Improvement)(at least 6, 12 weeks interval from baseline)
Study Sites (4)
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