Study to Evaluate the Efficacy and Safety of Aripiprazole

Overview

– 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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2016

Detailed Description

1. Study design – Multi-national, Multi-center, 52 weeks open label, single arm design

Interventions

  • Drug: Aripiprazole

Arms, Groups and Cohorts

  • Experimental: Aripiprazole
    • Dose level: 2, 5, 10, 15 mg/day Starting dose: 2 mg/day Dose increment: The dose should be gradually increased according to the investigator’s judgment of subject’s response. Target dose: 5-15 mg/day Maximum dose: 15 mg/day Flexibly dosed (2 to 15 mg/day) aripiprazole (oral tablet or solution) is taken once in a day at the same time without regarding to meals

Clinical Trial Outcome Measures

Primary Measures

  • irritability subscale of the aberrant behavior checklist
    • Time Frame: Week 12
    • 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

Secondary Measures

  • Change from baseline in ABC-subscale of lethargy/social withdrawal, stereotypic behavior, hyperactivity, inappropriate speech
    • Time Frame: Week 1, 2, 4, 8, 12, 24, 36, 52
    • ABC Scale will be completed by subject
  • Change of CGI-S, CGI-I from baseline
    • Time Frame: Week 1, 2, 4, 8, 12, 24, 36, 52
    • CGI-S, CGI-I scale will be evaluated by investigator
  • Change of Behavioral problems from baseline
    • Time Frame: Week 12, 52
    • Behavioral problems scale: Child Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
  • Change of Adaptive Skills from baseline
    • Time Frame: week 12, 52
    • Adaptive Skills Scale: Vineland Adaptive Behavior Scale (VABS)
  • Change of Parental stress from baseline
    • Time Frame: Weekk 12, 52
    • Parental stress scale: Parenting Stress Index (PSI)

Participating in This Clinical Trial

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 ≤ 1.0×10^3/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

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yoo-Sook Joung
  • Collaborator
    • Korea Otsuka International Asia Arab
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Yoo-Sook Joung, Professor – Samsung Medical Center
  • Overall Official(s)
    • Yoo-Sook Joung, MD. PhD., Principal Investigator, Sumsung Medical Center
  • Overall Contact(s)
    • Hyemi Cheon, 82-70-4033-3059, cheon.hyemi@cnrres.co.kr

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