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The objective of this study is to investigate the safety and efficacy of aripiprazole orally administered over long term in subjects who complete a short-term treatment study of pediatric Autistic Disorder (031-11-002 study).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aripiprazole | Experimental | administered orally once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | Flexibly dose administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score | The ABC-J Irritability subscale consists of 15 items. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Individual scores were summed, therefore, the overall score range was between 0-45. Higher scores represent worse condition. | Baseline, the final administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hiroaki Ono, Mr | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chubu Region | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28941259 | Derived | Ichikawa H, Hiratani M, Yasuhara A, Tsujii N, Oshimo T, Ono H, Tadori Y. An open-label extension long-term study of the safety and efficacy of aripiprazole for irritability in children and adolescents with autistic disorder in Japan. Psychiatry Clin Neurosci. 2018 Feb;72(2):84-94. doi: 10.1111/pcn.12607. Epub 2017 Nov 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aripiprazole | Aripiprazole was orally administered once daily to the subjects who completed the 031-11-002 study until the new indication of irritability in pediatric autistic disorder was approved, if not discontinued. The starting dose was 1 mg/day, and the dose was escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aripiprazole | Aripiprazole was orally administered once daily to the subjects who completed the 031-11-002 study until the new indication of irritability in pediatric autistic disorder was approved, if not discontinued. The starting dose was 1 mg/day, and the dose was escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score | The ABC-J Irritability subscale consists of 15 items. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Individual scores were summed, therefore, the overall score range was between 0-45. Higher scores represent worse condition. | Posted | Mean | Standard Deviation | units on a scale | Baseline, the final administration |
|
From the start date of investigational medicinal product (IMP) administration to date of the final examination
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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 was orally administered once daily to the subjects who completed the 031-11-002 study until the new indication of irritability in pediatric autistic disorder was approved, if not discontinued. The starting dose was 1 mg/day, and the dose was escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malaise | General disorders | MedDRA/J 19.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis allergic | Eye disorders | MedDRA/J 19.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., Ltd. | +81-3-6361-7366 |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
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| Chugoku Region |
| Japan |
| Kanto Region | Japan |
| Kinki Region | Japan |
| Kyushu Region | Japan |
| Withdrawal by Subject |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 10 |
| 86 |
| 84 |
| 86 |
| Lymphadenitis bacterial | Infections and infestations | MedDRA/J Ver 19.0 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA/J Ver 19.0 | Systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J Ver 19.0 | Systematic Assessment |
|
| Autism | Nervous system disorders | MedDRA/J Ver 19.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA/J Ver 19.0 | Systematic Assessment |
|
| Glomerulonephritis acute | Renal and urinary disorders | MedDRA/J Ver 19.0 | Systematic Assessment |
|
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA/J Ver 19.0 | Systematic Assessment |
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| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA/J Ver 19.0 | Systematic Assessment |
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| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA/J Ver 19.0 | Systematic Assessment |
|
| Sexual abuse | Social circumstances | MedDRA/J Ver 19.0 | Systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA/J Ver 19.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA/J Ver 19.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA/J Ver 19.0 | Systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA/J Ver 19.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA/J Ver 19.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA/J Ver 19.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA/J Ver 19.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA/J Ver 19.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA/J Ver 19.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA/J Ver 19.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA/J Ver 19.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA/J Ver 19.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA/J Ver 19.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA/J Ver 19.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA/J Ver 19.0 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA/J Ver 19.0 | Systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | MedDRA/J Ver 19.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA/J Ver 19.0 | Systematic Assessment |
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| Autism | Nervous system disorders | MedDRA/J Ver 19.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA/J Ver 19.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA/J Ver 19.0 | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA/J Ver 19.0 | Systematic Assessment |
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| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA/J Ver 19.0 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA/J Ver 19.0 | Systematic Assessment |
|
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| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |