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ABF Tourette's Disorder Post Marketing Surveillance Study

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ClinicalTrials.gov Identifier: NCT01795105
Recruitment Status : Completed
First Posted : February 20, 2013
Results First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Korea Otsuka Pharmaceutical Co., Ltd.

Brief 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).

Condition or disease
Tourette's Disorder

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.

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Study Type : Observational
Actual Enrollment : 692 participants
Observational Model: Case-Only
Time Perspective: Prospective
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"
Study Start Date : June 2012
Actual Primary Completion Date : May 29, 2015
Actual Study Completion Date : May 29, 2015

Resource links provided by the National Library of Medicine


Group/Cohort
Aripiprazole (Abilify® Tablets/Abilify® ODT)



Primary Outcome Measures :
  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 Outcome Measures :
  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

    1. Normal, not at all ill
    2. Borderline ill
    3. Mildly ill
    4. Moderately ill
    5. Markedly ill
    6. Severely ill
    7. Extremely ill



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pediatric patients 6 to 18 years of age with Tourette's Disorder according to the approved product market authorization
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01795105


Locations
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Korea, Republic of
Inha University Hospital
Incheon, Korea, Republic of
Chonbuk National University Hospital
Jeonju, Korea, Republic of, 561-712
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Seoul Medical Center
Seoul, Korea, Republic of, 131-795
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co., Ltd.
  Study Documents (Full-Text)

Documents provided by Korea Otsuka Pharmaceutical Co., Ltd.:
Study Protocol  [PDF] February 28, 2014


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Responsible Party: Korea Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01795105     History of Changes
Other Study ID Numbers: 031-KOA-1101n
First Posted: February 20, 2013    Key Record Dates
Results First Posted: April 1, 2019
Last Update Posted: April 1, 2019
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Tourette Syndrome
Psychotropic Drugs
Disease
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders
Aripiprazole
Antidepressive Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists