Study to Evaluate the Efficacy and Safety of Aripiprazole

Autism Clinical Trial

Official title:

A Multinational, Multicenter, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Aripiprazole in Asian Pediatric Patients With Autism Spectrum Disorder and Behavior Problems

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02069977
• Other study ID #: 031OTC1301
• Status: Recruiting
• Phase: Phase 4
• First received: February 13, 2014
• Last updated: March 10, 2014
• Start date: February 2014
• Est. completion date: February 2016

Study information

• Verified date: March 2014
• Source: Samsung Medical Center
• Contact: Hyemi Cheon
• Phone: 82-70-4033-3059
• Email: cheon.hyemi[@]cnrres.co.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review BoardThailand: Ethical CommitteePhilippines: Ethics CommitteePhilippines : Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

• To evaluate the efficacy of flexibly dosed aripiprazole in reducing serious behavioral problems in Asian children and adolescents with a diagnosis of autism spectrum disorder, as measured by change from baseline to endpoint on the irritability subscale of the aberrant behavior checklist (ABC-I).

• To evaluate the long-term safety and tolerability of flexibly dosed aripiprazole in the treatment of serious behavioral problems in Asian children and adolescents with a diagnosis of autism spectrum disorder.

Description:

1. Study design

• Multi-national, Multi-center, 52 weeks open label, single arm design

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 79
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

• 6 to 17 years of age.

• Meeting the diagnostic criteria for autistic disorder specified by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR), with a diagnosis corroborated by the Autism Diagnostic Interview-Revised (ADI-R) diagnostic instrument and demonstrated behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these.

• Clinical Global Impressions (CGI) Severity subscale score = 4 at screening and baseline.

• Aberrant Behavior Checklist (ABC) Irritability subscale score =18 at screening and baseline.

• Mental age = 18 months.

• Women of childbearing potential (WOCBP) have to use an adequate method of contraception

• WOCBP must have had a negative serum or urine pregnancy test.

• The patient and/or the designated guardian(s) or caregiver(s) who are able to comprehend and comply with the protocol requirements, in the opinion of the investigator and have consented to participate by signing an informed consent form.

Exclusion Criteria:

• Current diagnosis of bipolar disorder, schizophrenia, major depressive disorder, Rett's disorder, or Fragile-X syndrome.

• History of neuroleptic malignant syndrome.

• Significant risk of committing suicide based on history or routine psychiatric status examination.

• History of seizure in the past 1 year.

• History of severe head trauma or stroke

• History or current evidence of any unstable medical conditions

• Patient considered treatment resistant to neuroleptic medication

• Patient considered treatment resistant to aripiprazole

• Woman who is pregnant or breastfeeding

• ECG: QTc > 475 msec

• Platelets = 75,000/µL

• Hemoglobin = 9 g/dL

• Neutrophils = 1.0x10^3/µL

• Aspartate or alanine transaminase (AST or ALT) > 3xULN

• Serum creatinine = 2 mg/dL

• Patient weighed < 15 kg

• Patient who participated in any other clinical trial within 4 weeks

• Patient determined to require the administration of the prohibited medications during the study period

• Patient with other conditions determined by the investigator to be inappropriate for this clinical study

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism

Intervention

Drug:
• Aripiprazole

Locations

Country	Name	City	State
Korea, Republic of	Inje University Ilsan Paik Hospital	Ilsan	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Philippines	Medical City	Pasig
Philippines	Philippine Children's Medical Center	Quezon City
Thailand	Siriraj Hospital Mahidol University	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Yoo-Sook Joung	Korea Otsuka International Asia Arab

Countries where clinical trial is conducted

Korea, Republic of,  Philippines,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events (AEs)	Safety will be evaluated based on below inormaiton.; Laboratory test results (routine lab. and serum prolactin); Vital signs (blood pressure, pulse, body temperature); ECG; Weight gain; Extrapyramidal side effects (EPSEs) assessed by Simpson-Angus Rating Scale (SAS), Barnes Akathisia Rating Scale (BARS), and Abnormal Involuntary Movement Scale (AIMS)	Week 1, 2, 4, 8, 12, 24, 36, 52	Yes
Primary	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	No
Secondary	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	No
Secondary	Change of CGI-S, CGI-I from baseline	CGI-S, CGI-I scale will be evaluated by investigator	Week 1, 2, 4, 8, 12, 24, 36, 52	No
Secondary	Change of Behavioral problems from baseline	Behavioral problems scale: Child Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)	Week 12, 52	No
Secondary	Change of Adaptive Skills from baseline	Adaptive Skills Scale: Vineland Adaptive Behavior Scale (VABS)	week 12, 52	No
Secondary	Change of Parental stress from baseline	Parental stress scale: Parenting Stress Index (PSI)	Weekk 12, 52	No