ABF Tourette's Disorder Post Marketing Surveillance Study

Otsuka

Status: Completed

Conditions: Tourette's Disorder

Study type: Observational

Funder types: Industry

Identifiers

NCT01795105

031-KOA-1101n

Details and patient eligibility

About

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).

Full 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.

Enrollment: 692 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

692 participants in 1 patient group

Aripiprazole (Abilify® Tablets/Abilify® ODT)