NCT07773883Enrolling By Invitation3 期
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
This study is a Phase 3, multi-center, open-label trial to evaluate the long-term safety of solriamfetol in children and adolescents with ADHD.
详细描述
Eligible subjects are children and adolescents with ADHD who have completed either Study SOL-ADHD-302 (FOCUS-2) or Study SOL-ADHD-304 (FOCUS-3). Subjects will be assigned to age-based cohorts and will receive solriamfetol once daily for up to 52 weeks.
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed Study SOL-ADHD-302 (FOCUS-2) or Study SOL-ADHD-304 (FOCUS-3).
- •Has a parent/legal guardian to provide written informed consent and/or is willing to provide written informed assent to participate in the study.
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
Solriamfetol
Experimental
Up to 52 weeks
干预措施: Solriamfetol (Drug)
结局指标
主要结局
Treatment-Emergent Adverse Events (TEAEs)
时间窗: Up to 52 weeks
An AE is defined as treatment emergent if the first onset or worsening is after the first administration of the study drug and not more than 7 days after the last dose of study drug or 30 days after the last dose of study drug for SAEs.
次要结局
未报告次要终点
研究者
研究点 (3)
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