ABF Tourette's Disorder Post Marketing Surveillance Study

Tourette's Disorder Clinical Trial

Official title:

Post-Marketing Surveillance of Safety and Efficacy of Abilify® Tablets in Korean Patients With Tourette's Disorder Under the "New Drug Re-Examination"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01795105
• Other study ID #: 031-KOA-1101n
• Status: Completed
• Start date: June 2012
• Est. completion date: May 29, 2015

Study information

• Verified date: January 2018
• Source: Korea Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 692
• Est. completion date: May 29, 2015
• Est. primary completion date: May 29, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Tourette Syndrome
• Tourette's Disorder

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Chonbuk National University Hospital	Jeonju
Korea, Republic of	Seoul Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency (n) of Subjects With Adverse Event	Frequency (n) and Percentage(%) of subjects with Adverse event	Follow-up at least once from baseline to 6 weeks and at least 12weeks
Secondary	Mean Change in the TS-CGI(Tourette's Syndrome-Clinical Global Impression-Improvement)	Mean change in the TS-CGI from baseline to next visit(at least 6, 12 weeks interval from baseline) post-treatment; *TS-CGI scale 0=Not assessed; Normal, not at all ill; Borderline ill; Mildly ill; Moderately ill; Markedly ill; Severely ill; Extremely ill	at least 6, 12 weeks interval from baseline