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| Name | Class |
|---|---|
| Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Aripiprazole 2mg,5mg,10mg,15mg,20mg orally administrated Once a day (Titration according to the protocol) |
|
| 2 | Placebo Comparator | Placebo 2mg,5mg,10mg,15mg,20mg orally administrated Once a day (Titration according to the protocol) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aripiprazole | Drug | Initial dose : 2mg, Maximum dose : 20mg |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Change of Total Tic Scores in K-YGTSS From Randomization (Baseline, Visit 2) to the Final Visit (Visit 7) | 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. | 10 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soochurl Cho, MD. Ph.D | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inha University Hospital | Inchon | 400-711 | South Korea | |||
| Seoul National University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24021518 | Derived | Yoo HK, Joung YS, Lee JS, Song DH, Lee YS, Kim JW, Kim BN, Cho SC. A multicenter, randomized, double-blind, placebo-controlled study of aripiprazole in children and adolescents with Tourette's disorder. J Clin Psychiatry. 2013 Aug;74(8):e772-80. doi: 10.4088/JCP.12m08189. |
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antipsychotic or antiparkinson drugs should be washed out 1~2 weeks prior to randomization.
Recruitment period :Aug2008~Jan2010 Types of location: Medical Center
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| ID | Title | Description |
|---|---|---|
| FG000 | Aripiprazole | Aripiprazole 2mg,5mg,10mg,15mg, 20mg orally administrated Once a day (Titration according to the protocol) Mode of administration: P.O |
| FG001 | Placebo | Placebo 2mg,5mg,10mg,15mg, 20mg orally administrated Once a day (Titration according to the protocol)10mg,15mg, 20mg Mode of administration: P.O |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo | Drug | Initial dose: 2mg, Maximum dose:20mg |
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| Seoul |
| 110-744 |
| South Korea |
| Yonsei University Severance Hospital | Seoul | 120-752 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| Chung-Ang Univ. Medical center | Seoul | 156-755 | South Korea |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aripiprazole | Aripiprazole 2mg,5mg,10mg,15mg |
| BG001 | Placebo | Placebo 2mg,5mg,10mg,15mg |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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. | Not Posted | Mean | participants | 10 weeks | ||||||||||||||||||||||||||||||||||
| Primary | Mean Change of Total Tic Scores in K-YGTSS From Randomization (Baseline, Visit 2) to the Final Visit (Visit 7) | 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. | ITT (Intention-To-Treat)analysis | Posted | Jan 2011 | Mean | Full Range | units on a scale | 10 week |
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14 week
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aripiprazole | Aripiprazole 2mg,5mg,10mg,15mg | 0 | 32 | 24 | 32 | ||
| EG001 | Placebo | Placebo 2mg,5mg,10mg,15mg | 0 | 28 | 20 | 28 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sedation | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
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| Akathisia | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
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| Extrapyramidal disorder | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
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| Dystonia | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 11.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA version 11.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 11.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 11.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA version 11.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA version 11.0 | Systematic Assessment |
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| Irritability | General disorders | MedDRA version 11.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA version 11.0 | Systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | MedDRA version 11.0 | Systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDRA version 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Kiho Moon | +82-2-3287-9009 | khmoon@otsuka.co.kr |
| ID | Term |
|---|---|
| D013981 | Tic Disorders |
| D005879 | Tourette Syndrome |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| >=65 years |
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| Male |
|