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Completed

NCT Number: NCT01795105

ABF Tourette's Disorder Post Marketing Surveillance Study

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).

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Key information

Conditions

Tourette's Disorder Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurodevelopmental Disorders Tic Disorders Tourette Syndrome

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Inha University Hospital, Incheon, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Frequency (n) of Subjects With Adverse Event

    Time frame: Follow-up at least once from baseline to 6 weeks and at least 12weeks

    Frequency (n) and Percentage(%) of subjects with Adverse event

Secondary outcomes

  1. Mean Change in the TS-CGI(Tourette's Syndrome-Clinical Global Impression-Improvement)

    Time frame: at least 6, 12 weeks interval from baseline

    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

Sponsors and collaborators

Lead sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 20, 2013
Registry last updated
Apr 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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