N/A
Completed N=692
ABF Tourette's Disorder Post Marketing Surveillance Study
Tourette's Disorder
Source: ClinicalTrials.gov NCT01795105 ↗
Enrolled (actual)
692
Serious AEs
0.2%
Results posted
Apr 2019
Primary outcomePrimary: Frequency (n) of Subjects With Adverse Event — 50; 19; 42; 14 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency (n) of Subjects With Adverse Event |
50; 19; 42; 14 | — |
| SECONDARY Mean Change in the TS-CGI(Tourette's Syndrome-Clinical Global Impression-Improvement) |
4.31; 4.34; 2.73; 2.66; -1.58; -1.69 | — |
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
Data sourced from ClinicalTrials.gov (NCT01795105). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.