NCT01795105

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"

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 692 (actual)
• Sponsor: Korea Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tourette's Disorder

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-05-29
• Completion: 2015-05-29
• First posted: 2013-02-20
• Last updated: 2019-04-01
• Results posted: 2019-04-01

Locations

4 sites across 1 country: South Korea