A Phase 3, Randomized, 6-Week, Double-blind, Placebo-controlled Trial of Solriamfetol in Children Aged 6 to <12 Years With Attention Deficit Hyperactivity Disorder (ADHD)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 468
- 试验地点
- 23
- 主要终点
- ADHD-RS-5 Total Score, Change from Baseline to Week 6
研究概览
简要总结
This study is a Phase 3, multi-center, randomized, 6-week, double-blind, placebo-controlled, parallel-group trial to assess the efficacy and safety of solriamfetol in children aged 6 to <12 years with ADHD.
详细描述
Eligible subjects are children, 6 to <12 years of age, with a primary diagnosis of ADHD based on criteria established by the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to receive solriamfetol dose A, solriamfetol dose B or placebo once daily for 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 6 to <12 years.
- •Primary diagnosis of ADHD according to DSM-5 criteria.
- •Has parents/legal guardians provide written informed consent and has child provide written informed assent to participate in the study before the conduct of any study procedures.
排除标准
- •Unable to comply with study procedures.
- •Medically inappropriate for study participation in the opinion of the investigator.
研究组 & 干预措施
Placebo
Up to 6 weeks
干预措施: Placebo (Drug)
Solriamfetol Dose A
Up to 6 weeks
干预措施: Solriamfetol Dose A (Drug)
Solriamfetol Dose B
Up to 6 weeks
干预措施: Solriamfetol Dose B (Drug)
结局指标
主要结局
ADHD-RS-5 Total Score, Change from Baseline to Week 6
时间窗: 6 weeks
Attention Deficit/ Hyperactivity Disorder Rating Scale-5, Interview with Informant, Child Version (ADHD-RS-5)
次要结局
未报告次要终点