EUCTR2019-000723-40-Outside-EU/EEA进行中（未招募）1 期
Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Primary Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of ASD
- •Aberrant Behavior checklist – Irritability (ABC-I) subscale score of = 18
- •Clinical Global Impressions - Severity (CGI-S) scale score pertaining to irritability = 4
- •Mental age of = 2 years as determined by Investigator based upon school participation, social history or medical records
- •Ability for parent/caregiver to follow all protocol procedures
- •Able to swallow tablets
- •Able to discontinue all prohibited concomitant medications to meet protocol required washouts prior to and during the trial period
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 119
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Primary diagnosis of bipolar I disorder, including any DSM-5 current diagnosis of bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode, and post-traumatic stress disorder (PTSD).
- •Attention-deficit/hyperactivity disorder (ADHD) maybe exclusionary if it is the primary disorder, or is not stable or adequately treated.
- •current or historical diagnosis of Fragile-X Syndrome or Rett’s Disorder
- •history of neuroleptic malignant syndrome
- •a significant risk of committing violent acts, serious self-harm, or suicide
- •epilepsy, a history of seizures, or a history of severe head trauma or stroke, or have a history or current evidence of other unstable medical conditions
- •current hypothyroidism or hyperthyroidism
- •uncontrolled Type I or Type II diabetes
- •uncontrolled hypertension or symptomatic hypotension, or orthostatic hypotension
- •Weight < 15 kg
- •Previous exposure to brexpiprazole
- •Sexually active males or females, who could become pregnant, not agreeing to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days at the end of the study
研究者
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