ABF Tourette's Disorder Post Marketing Surveillance Study

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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)

Trial documents
1

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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