A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of Solriamfetol in Adults With ADHD.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 516
- 试验地点
- 42
- 主要终点
- Change from Baseline to Week 6 in the AISRS total score
研究概览
简要总结
FOCUS (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and safety of solriamfetol in adults with ADHD.
详细描述
Eligible subjects must have a primary diagnosis of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria. Subjects will be randomized in a 1:1:1 ratio to be treated with solriamfetol 150 mg, solriamfetol 300 mg, 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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of ADHD according to DSM-5 criteria.
- •Provides written informed consent to participate in the study before the conduct of any study procedures.
- •Male or female, aged 18 to 55 inclusive.
排除标准
- •Prior exposure to solriamfetol/Sunosi, through either a clinical study or prescription.
- •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 150 mg
Up to 6 weeks
干预措施: Solriamfetol 150 mg (Drug)
Solriamfetol 300 mg
Up to 6 weeks
干预措施: Solriamfetol 300 mg (Drug)
Placebo
Up to 6 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline to Week 6 in the AISRS total score
时间窗: 6 weeks
Adult ADHD Investigator Symptom Report Scale (AISRS)
次要结局
未报告次要终点