NCT02069977Unknown4 期
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
Yoo-Sook Joung6 个研究点 分布在 3 个国家目标入组 79 人开始时间: 2014年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 79
- 试验地点
- 6
- 主要终点
- irritability subscale of the aberrant behavior checklist
研究概览
简要总结
- 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.
详细描述
- Study design
- Multi-national, Multi-center, 52 weeks open label, single arm design
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Aripiprazole
Experimental
- 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
干预措施: Aripiprazole (Drug)
结局指标
主要结局
irritability subscale of the aberrant behavior checklist
时间窗: 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
次要结局
- Change from baseline in ABC-subscale of lethargy/social withdrawal, stereotypic behavior, hyperactivity, inappropriate speech(Week 1, 2, 4, 8, 12, 24, 36, 52)
- Change of CGI-S, CGI-I from baseline(Week 1, 2, 4, 8, 12, 24, 36, 52)
- Change of Behavioral problems from baseline(Week 12, 52)
- Change of Adaptive Skills from baseline(week 12, 52)
- Change of Parental stress from baseline(Weekk 12, 52)
研究者
Yoo-Sook Joung
Professor
Samsung Medical Center
研究点 (6)
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