EUCTR2018-004899-35-Outside-EU/EEA进行中（未招募）1 期
A Phase 3, Multicenter, Open Label Trial to Evaluate the Long-term Safety and Tolerability 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
- •5 to 17 year of age or turned 18 while enrolled in the 331-201-00148 study
- •Autism Spectrum Disorder
- •Completion of 331-201-00148 trial
- •Investigator assessment
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 95
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 1
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Did not complete treatment period or incurred significant protocol deviations during 331-201-00148 study
- •Sexually active males or female of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose
- •Female with positive pregnancy test
研究者
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