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| Name | Class |
|---|---|
| Korea Otsuka International Asia Arab | INDUSTRY |
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1. Study design
- Multi-national, Multi-center, 52 weeks open label, single arm design
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aripiprazole | Experimental |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug |
|
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| Measure | Description | Time Frame |
|---|---|---|
| irritability subscale of the aberrant behavior checklist | Mean change from baseline to endpoint of Part 1 (week 12)in the caregiver-rated ABC Irritability (ABC-I) subscale score. ABC Scale will be completed by subject | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in ABC-subscale of lethargy/social withdrawal, stereotypic behavior, hyperactivity, inappropriate speech | ABC Scale will be completed by subject | Week 1, 2, 4, 8, 12, 24, 36, 52 |
| Change of CGI-S, CGI-I from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Safety will be evaluated based on below inormaiton.
| Week 1, 2, 4, 8, 12, 24, 36, 52 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyemi Cheon | Contact | 82-70-4033-3059 | cheon.hyemi@cnrres.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Yoo-Sook Joung, MD. PhD. | Sumsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical City | Not yet recruiting | Pasig | Philippines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36112116 | Derived | Kim BU, Kim HW, Park EJ, Kim JH, Boon-Yasidhi V, Tarugsa J, Reyes A, Manalo SG, Joung YS. Long-Term Improvement and Safety of Aripiprazole for Irritability and Adaptive Function in Asian Children and Adolescents with Autistic Disorder: A 52-Week, Multinational, Multicenter, Open-Label Study. J Child Adolesc Psychopharmacol. 2022 Sep;32(7):390-399. doi: 10.1089/cap.2022.0004. |
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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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CGI-S, CGI-I scale will be evaluated by investigator
| Week 1, 2, 4, 8, 12, 24, 36, 52 |
| Change of Behavioral problems from baseline | Behavioral problems scale: Child Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) | Week 12, 52 |
| Change of Adaptive Skills from baseline | Adaptive Skills Scale: Vineland Adaptive Behavior Scale (VABS) | week 12, 52 |
| Change of Parental stress from baseline | Parental stress scale: Parenting Stress Index (PSI) | Weekk 12, 52 |
| Philippine Children's Medical Center | Not yet recruiting | Quezon City | Philippines |
|
| Inje University Ilsan Paik Hospital | Recruiting | Ilsan | Gyeonggi-do | 411-706 | South Korea |
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| Samsung Medical Center | Recruiting | Seoul | 135-710 | South Korea |
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| Asan Medical Center | Not yet recruiting | Seoul | 138-736 | South Korea |
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| Siriraj Hospital Mahidol University | Not yet recruiting | Bangkok | 10700 | Thailand |
|
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |