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The objective of this study is to investigate the efficacy and safety of aripiprazole orally administered over a period of 8 weeks in pediatric patients with Autistic Disorder
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | administered orally once daily |
|
| Aripiprazole | Experimental | administered orally once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo of Aripiprazole | Drug | administered orally once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in the 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, 8 weeks after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyoji Imaoka, Mr | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chubu Region | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37811711 | Derived | Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aripiprazole | Aripiprazole were orally administered once daily for 8 weeks. The starting dose was 1 mg/day, and the dose will be escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8. |
| FG001 | Placebo | Placebo were orally administered once daily for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aripiprazole | Aripiprazole were orally administered once daily for 8 weeks. The starting dose was 1 mg/day, and the dose will be escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8. |
| BG001 |
| 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 in the 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 Error | units on a scale | baseline, 8 weeks after dosing |
|
From the start date of investigational medicinal product (IMP) administration to date of the final examination (up to Week 8 at e hours after IMP administration)
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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 were orally administered once daily for 8 weeks. The starting dose was 1 mg/day, and the dose will be escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heat illness | Injury, poisoning and procedural complications | MedDRA/J Version 17. | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA/J Version 17. | 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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| Aripiprazole |
| Drug |
Flexibly dose administered orally once daily |
|
| Chugoku Region |
| Japan |
| Kanto Region | Japan |
| Kinki Region | Japan |
| Kyushu Region | Japan |
| Placebo |
Placebo were orally administered once daily for 8 weeks. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Placebo |
Placebo were orally administered once daily for 8 weeks. |
|
|
| 0 |
| 47 |
| 39 |
| 47 |
| EG001 | Placebo | Placebo were orally administered once daily for 8 weeks. | 1 | 45 | 32 | 45 |
| Vomiting | Gastrointestinal disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Malaise | General disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA/J Version 17. | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA/J Version 17. | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA/J Version 17. | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Conjunctivitis allergic | Eye disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Glossitis | Gastrointestinal disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Salivary hypersecretion | Gastrointestinal disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Perianal erythema | Gastrointestinal disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Decreased activity | General disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Gait disturbance | General disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Local swelling | General disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Thirst | General disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Gingivitis | Infections and infestations | MedDRA/J Version 17. | Systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA/J Version 17. | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA/J Version 17. | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA/J Version 17. | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA/J Version 17. | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA/J Version 17. | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA/J Version 17. | Systematic Assessment |
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| Enteritis infectious | Infections and infestations | MedDRA/J Version 17. | Systematic Assessment |
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| Streptococcal infection | Infections and infestations | MedDRA/J Version 17. | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA/J Version 17. | Systematic Assessment |
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| Arthropod sting | Injury, poisoning and procedural complications | MedDRA/J Version 17. | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA/J Version 17. | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA/J Version 17. | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA/J Version 17. | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA/J Version 17. | Systematic Assessment |
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| Weight increased | Investigations | MedDRA/J Version 17. | Systematic Assessment |
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| Hyperphagia | Metabolism and nutrition disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Polydipsia | Metabolism and nutrition disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Akathisia | Nervous system disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Autism | Nervous system disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Bradykinesia | Nervous system disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Disturbance in attention | Nervous system disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Speech disorder | Nervous system disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Apathy | Psychiatric disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Emotional disorder | Psychiatric disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Intentional self-injury | Psychiatric disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Parasomnia | Psychiatric disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Self injurious behaviour | Psychiatric disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Polyuria | Renal and urinary disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Laryngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Miliaria | Skin and subcutaneous tissue disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Seborrhoea | Skin and subcutaneous tissue disorders | MedDRA/J Version 17. | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA/J Version 17. | Systematic Assessment |
|
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| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |