ABF Tourette's Disorder Post Marketing Surveillance Study

Sponsor
Korea Otsuka Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01795105
Collaborator
(none)
692
4
35.9
173
4.8

Study Details

Study Description

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 Intervention/Treatment Phase

    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.

    Study Design

    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 :
    Jun 1, 2012
    Actual Primary Completion Date :
    May 29, 2015
    Actual Study Completion Date :
    May 29, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Aripiprazole (Abilify® Tablets/Abilify® ODT)

    Outcome Measures

    Primary Outcome Measures

    1. Frequency (n) of Subjects With Adverse Event [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) [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Inha University Hospital Incheon Korea, Republic of
    2 Chonbuk National University Hospital Jeonju Korea, Republic of 561-712
    3 Seoul National University Hospital Seoul Korea, Republic of 110-744
    4 Seoul Medical Center Seoul Korea, Republic of 131-795

    Sponsors and Collaborators

    • Korea Otsuka Pharmaceutical Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Korea Otsuka Pharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT01795105
    Other Study ID Numbers:
    • 031-KOA-1101n
    First Posted:
    Feb 20, 2013
    Last Update Posted:
    Apr 1, 2019
    Last Verified:
    Jan 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Aripiprazole (Abilify® Tablets/Abilify® ODT)
    Arm/Group Description Pediatric patients 6 to 18 years of age with Tourette's Disorder Patients who are prescribed Abilify® Tablets/Abilify® ODT treatment as per investigator's medical judgment. Dose: Aripiprazole (Abilify® Tablets 2mg, 5mg, 10mg, 15mg, Abilify® ODT 10mg, 15mg)
    Period Title: Overall Study
    STARTED 692
    COMPLETED 648
    NOT COMPLETED 44

    Baseline Characteristics

    Arm/Group Title Aripiprazole (Abilify® Tablets/Abilify® ODT)
    Arm/Group Description Pediatric patients with Tourette syndrome aged 6-18 years who were administered with Aripiprazole (Abilify® Tablets/Abilify® ODT) according to the approved dosage.
    Overall Participants 648
    Age, Customized (Count of Participants)
    >=6 years and <12 years
    449
    69.3%
    >=12 years and <18 years
    199
    30.7%
    Sex: Female, Male (Count of Participants)
    Female
    114
    17.6%
    Male
    533
    82.3%

    Outcome Measures

    1. Primary Outcome
    Title Frequency (n) of Subjects With Adverse Event
    Description Frequency (n) and Percentage(%) of subjects with Adverse event
    Time Frame Follow-up at least once from baseline to 6 weeks and at least 12weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Aripiprazole Main Surveillance Aripiprazole Long-term Surveillance
    Arm/Group Description Patients who were given Abilify Tablet or Abilify OD Tablet for at least 6 weeks or longer. Patients who were given Abilify Tablet or Abilify OD Tablet for at least 12 weeks.
    Measure Participants 648 233
    Number of patients reported for AE
    50
    7.7%
    19
    NaN
    Number of patients reported for ADR
    42
    6.5%
    14
    NaN
    2. Secondary Outcome
    Title Mean Change in the TS-CGI(Tourette's Syndrome-Clinical Global Impression-Improvement)
    Description 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
    Time Frame at least 6, 12 weeks interval from baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Aripiprazole Main Surveillance Aripiprazole Long-term Surveillance
    Arm/Group Description Patients who were given Abilify Tablet or Abilify OD Tablet for at least 6 weeks or longer. Patients who were given Abilify Tablet or Abilify OD Tablet for at least 12 weeks.
    Measure Participants 589 233
    at the first visit
    4.31
    (0.81)
    4.34
    (0.86)
    at the last visit
    2.73
    (0.83)
    2.66
    (0.80)
    Mean change in the TS-CGI
    -1.58
    (0.95)
    -1.69
    (0.93)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Aripiprazole (Abilify® Tablets/Abilify® ODT)
    Arm/Group Description
    All Cause Mortality
    Aripiprazole (Abilify® Tablets/Abilify® ODT)
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Aripiprazole (Abilify® Tablets/Abilify® ODT)
    Affected / at Risk (%) # Events
    Total 1/648 (0.2%)
    Nervous system disorders
    Neuritis 1/648 (0.2%) 1
    Other (Not Including Serious) Adverse Events
    Aripiprazole (Abilify® Tablets/Abilify® ODT)
    Affected / at Risk (%) # Events
    Total 49/648 (7.6%)
    Gastrointestinal disorders
    Nausea 9/648 (1.4%) 10
    Dyspepsia 2/648 (0.3%) 2
    Mouth dry 1/648 (0.2%) 1
    Vomiting 1/648 (0.2%) 1
    Constipation 1/648 (0.2%) 1
    Diarrhoea 1/648 (0.2%) 1
    Enteritis 1/648 (0.2%) 1
    General disorders
    Fatigue 1/648 (0.2%) 1
    Metabolism and nutrition disorders
    Weight increase 1/648 (0.2%) 1
    Nervous system disorders
    Extrapyramidal disorder 4/648 (0.6%) 5
    Hyperkinesia 3/648 (0.5%) 3
    Hypertonia 2/648 (0.3%) 2
    Headache 2/648 (0.3%) 2
    Dizziness 2/648 (0.3%) 2
    Tremor 1/648 (0.2%) 1
    Psychiatric disorders
    Somnolence 16/648 (2.5%) 16
    Appetite increased 4/648 (0.6%) 4
    Anorexia 2/648 (0.3%) 2
    Apathy 1/648 (0.2%) 1
    Nervousness 2/648 (0.3%) 2
    Emotional liability 1/648 (0.2%) 1
    Anxiety 1/648 (0.2%) 1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis 1/648 (0.2%) 1
    Pharyngitis 1/648 (0.2%) 1
    Skin and subcutaneous tissue disorders
    Eczema 1/648 (0.2%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Jeong, Hyo-Won
    Organization KoreaOtsukaPharma
    Phone
    Email jhw0159@otsuka.co.kr
    Responsible Party:
    Korea Otsuka Pharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT01795105
    Other Study ID Numbers:
    • 031-KOA-1101n
    First Posted:
    Feb 20, 2013
    Last Update Posted:
    Apr 1, 2019
    Last Verified:
    Jan 1, 2018