Clincosm LogoSign in Get a demo

Aripiprazole in Children and Adolescents With Chronic Tic Disorder or Tourette's Disorder

Sponsor
Korea Otsuka Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT00706589
Collaborator
Otsuka Pharmaceutical Co., Ltd. (Industry)
61
Enrollment
6
Locations
2
Arms
18
Duration (Months)
10.2
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this trial is to demonstrate the efficacy and safety of aripiprazole in children and adolescents aged 6~18 years with chronic tic disorders or Tourette's disorder

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
61 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Dose-adjustment, Placebo-controlled Study to Evaluate the Efficacy and Safety of Aripiprazole in Children and Adolescents With Chronic Tic Disorders or Tourette's Disorder
Study Start Date :
Oct 1, 2008
Actual Primary Completion Date :
Apr 1, 2010
Actual Study Completion Date :
Apr 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Aripiprazole 2mg,5mg,10mg,15mg,20mg orally administrated Once a day (Titration according to the protocol)

Drug: aripiprazole
Initial dose : 2mg, Maximum dose : 20mg
Other Names:
  • Abilify

    		•
    Placebo Comparator: 2

    Placebo 2mg,5mg,10mg,15mg,20mg orally administrated Once a day (Titration according to the protocol)

    Drug: placebo
    Initial dose: 2mg, Maximum dose:20mg

    Outcome Measures

    Primary Outcome Measures

    1. Mean Change of Total Tic Scores in K-YGTSS From Randomization (Baseline, Visit 2) to the Final Visit (Visit 7) [10 week]

      The meaning of the total tic scores is a sum of the total motor tic score and total phonic tic score and the total tic score will be indicated from zero point to 50 points. And also, for the global tic severity scale is sum of the total tic scores and impairment score and it will be indicated from zero point to 100 points. Additionally, for the imparment score is also indicated from zero to 50 points same as total tic scores. And it is divided as 0 point, 10 point, 20 point and etc… Lastly, someone who gets a high score, it will be considered worse result.

    Secondary Outcome Measures

    1. 1)Percent Change of Total Tic Scores on the Korean Version of YaleGlobalTicseverity Scale.2)Response Rate Assessed With the Tic Score ClinicalGlobalImpressionImprovementScale.3)Mean Change in Scores on the Tic Score ClinicalGlobal ImpressionSeverityScale. [10 weeks]

    Eligibility Criteria

    Criteria

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

    1. Patients who can provide an assent form signed by themselves and informed consent form by their legal representatives prior to performing of any study procedures.

    2. Male or female children and adolescents aged 6 to 18 years

    3. Patients who are diagnosed with chronic tic disorders(Motor or Phonic) or Tourette's disorder according to DSM-IV(Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition)(using K-SADS-PL-K (Kiddle-Schedule for Affective Disorders and Schizophrenia,Present and Lifetime Version-Korean version)) and require drug therapy.

    4. The total tic score of the K-YGTSS (Korean version of Yale Global Tic Severity Scale)is more than 22 at baseline

    Exclusion Criteria:

    1. Patients with secondary tic symptoms accompanied by Tardive tics, Huntington disease, neuroacanthocytosis, mental retardation, or autism

    2. Patients with IQ (Intelligence quotient) (assessed using KEDI-WISC (Korean educational Development Institute-Wechsler Intelligence Scale for children)) 70 and lower than 70

    3. Patients with a history of neuroleptic malignant syndrome

    4. Patients with antipsychotic or alcohol use disorder (abuse, dependence, and/or withdrawal) according to DSM-IV criteria for the past 3 months

    5. Patients with a history of allergy or hypersensitivity reaction to aripiprazole

    6. Patients with a history of resistance to treatment with antipsychotics

    7. Patients who have participated in another clinical study within 1 month prior to screening

    8. Patients who have previously taken aripiprazole or participated in a clinical study with aripiprazole

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Inha University Hospital Inchon Korea, Republic of 400-711
    2 Seoul National University Hospital Seoul Korea, Republic of 110-744
    3 Yonsei University Severance Hospital Seoul Korea, Republic of 120-752
    4 Samsung Medical Center Seoul Korea, Republic of 135-710
    5 Asan Medical Center Seoul Korea, Republic of 138-736
    6 Chung-Ang Univ. Medical center Seoul Korea, Republic of 156-755

    Sponsors and Collaborators

    • Korea Otsuka Pharmaceutical Co., Ltd.
    • Otsuka Pharmaceutical Co., Ltd.

    Investigators

    • Principal Investigator: Soochurl Cho, MD. Ph.D, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Korea Otsuka Pharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT00706589
    Other Study ID Numbers:
    • 031-KOA-0703
    First Posted:
    Jun 27, 2008
    Last Update Posted:
    Jul 26, 2013
    Last Verified:
    Jun 1, 2013
    Keywords provided by Korea Otsuka Pharmaceutical Co., Ltd.
    Chronic Motor Tic disorder
    Chronic Phonic Tic disorder
    Tourette's disorder
    Aripiprazole
    Abilify
    Children
    Adolescent
    Additional relevant MeSH terms:
    Tics
    Tic Disorders
    Tourette Syndrome
    Disease
    Aripiprazole

    Study Results

    Participant Flow

    Recruitment Details Recruitment period :Aug2008~Jan2010 Types of location: Medical Center
    Pre-assignment Detail antipsychotic or antiparkinson drugs should be washed out 1~2 weeks prior to randomization.
    Arm/Group Title Aripiprazole Placebo
    Arm/Group Description Aripiprazole 2mg,5mg,10mg,15mg, 20mg orally administrated Once a day (Titration according to the protocol) Mode of administration: P.O Placebo 2mg,5mg,10mg,15mg, 20mg orally administrated Once a day (Titration according to the protocol)10mg,15mg, 20mg Mode of administration: P.O
    Period Title: Overall Study
    STARTED 32 29
    COMPLETED 29 25
    NOT COMPLETED 3 4

    Baseline Characteristics

    Arm/Group Title Aripiprazole Placebo Total
    Arm/Group Description Aripiprazole 2mg,5mg,10mg,15mg Placebo 2mg,5mg,10mg,15mg Total of all reporting groups
    Overall Participants 32 29 61
    Age (Count of Participants)
    <=18 years
    32
    100%
    29
    100%
    61
    100%
    Between 18 and 65 years
    0
    0%
    0
    0%
    0
    0%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    10.97
    (2.49)
    10.93
    (3.00)
    10.95
    (2.72)
    Sex: Female, Male (Count of Participants)
    Female
    2
    6.3%
    6
    20.7%
    8
    13.1%
    Male
    30
    93.8%
    23
    79.3%
    53
    86.9%
    Region of Enrollment (participants) [Number]
    Korea, Republic of
    32
    100%
    29
    100%
    61
    100%

    Outcome Measures

    1. Secondary Outcome
    Title 1)Percent Change of Total Tic Scores on the Korean Version of YaleGlobalTicseverity Scale.2)Response Rate Assessed With the Tic Score ClinicalGlobalImpressionImprovementScale.3)Mean Change in Scores on the Tic Score ClinicalGlobal ImpressionSeverityScale.
    Description
    Time Frame 10 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    2. Primary Outcome
    Title Mean Change of Total Tic Scores in K-YGTSS From Randomization (Baseline, Visit 2) to the Final Visit (Visit 7)
    Description The meaning of the total tic scores is a sum of the total motor tic score and total phonic tic score and the total tic score will be indicated from zero point to 50 points. And also, for the global tic severity scale is sum of the total tic scores and impairment score and it will be indicated from zero point to 100 points. Additionally, for the imparment score is also indicated from zero to 50 points same as total tic scores. And it is divided as 0 point, 10 point, 20 point and etc… Lastly, someone who gets a high score, it will be considered worse result.
    Time Frame 10 week

    Outcome Measure Data

    Analysis Population Description
    ITT (Intention-To-Treat)analysis
    Arm/Group Title Aripiprazole Placebo
    Arm/Group Description Aripiprazole 2mg,5mg,10mg,15mg, 20mg Placebo 2mg,5mg,10mg,15mg, 20mg
    Measure Participants 31 29
    Mean (Full Range) [units on a scale]
    -9.62
    -14.97

    Adverse Events

    Time Frame 14 week
    Adverse Event Reporting Description A total of 60 subjects were included in the safety analysis; 28 in Placebo group and 32 in Aripiprazole group. Note that one subject who was randomized to Placebo group but took Aripiprazole due to prescription error was included in Aripiprazole group as per the actual administration for the safety analysis.
    Arm/Group Title Aripiprazole Placebo
    Arm/Group Description Aripiprazole 2mg,5mg,10mg,15mg Placebo 2mg,5mg,10mg,15mg
    All Cause Mortality
    Aripiprazole Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Aripiprazole Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/32 (0%) 0/28 (0%)
    Other (Not Including Serious) Adverse Events
    Aripiprazole Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 24/32 (75%) 20/28 (71.4%)
    Gastrointestinal disorders
    Nausea 6/32 (18.8%) 6 2/28 (7.1%) 3
    Dyspepsia 1/32 (3.1%) 1 2/28 (7.1%) 2
    Vomiting 0/32 (0%) 0 3/28 (10.7%) 4
    General disorders
    Irritability 0/32 (0%) 0 2/28 (7.1%) 2
    Infections and infestations
    Nasopharyngitis 4/32 (12.5%) 4 0/28 (0%) 0
    Upper respiratory tract infection 1/32 (3.1%) 1 2/28 (7.1%) 2
    Investigations
    Electrocardiogram QT prolonged 2/32 (6.3%) 2 1/28 (3.6%) 1
    Metabolism and nutrition disorders
    Anorexia 2/32 (6.3%) 2 1/28 (3.6%) 1
    Increased appetite 2/32 (6.3%) 2 0/28 (0%) 0
    Nervous system disorders
    Sedation 4/32 (12.5%) 5 3/28 (10.7%) 5
    Akathisia 2/32 (6.3%) 2 4/28 (14.3%) 5
    Headache 5/32 (15.6%) 5 1/28 (3.6%) 1
    Dizziness 1/32 (3.1%) 1 4/28 (14.3%) 4
    Extrapyramidal disorder 3/32 (9.4%) 3 2/28 (7.1%) 2
    Somnolence 4/32 (12.5%) 5 0/28 (0%) 0
    Dystonia 0/32 (0%) 0 2/28 (7.1%) 2
    Psychiatric disorders
    Insomnia 0/32 (0%) 0 3/28 (10.7%) 4

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    Results Point of Contact

    Name/Title Medical Director
    Organization Kiho Moon
    Phone +82-2-3287-9009
    Email khmoon@otsuka.co.kr
    Responsible Party:
    Korea Otsuka Pharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT00706589
    Other Study ID Numbers:
    • 031-KOA-0703
    First Posted:
    Jun 27, 2008
    Last Update Posted:
    Jul 26, 2013
    Last Verified:
    Jun 1, 2013