An Open-Label and Double-Blind, Randomized Withdrawal Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Adults With Binge Eating Disorder
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 236
- 试验地点
- 34
- 主要终点
- Long-term Safety
研究概览
简要总结
This is a Phase 3, multi-center, open-label and randomized withdrawal study to evaluate the long-term safety and efficacy of solriamfetol in the treatment of binge eating disorder (BED) in adults.
详细描述
This study includes three segments: Open-Label (OL), Double-Blind Randomized Withdrawal (RW), and Open-Label Return (OLR). Eligible subjects will have completed the SOL-BED-301 (ENGAGE) study. All subjects will receive open-label solriamfetol for up to 52 weeks during the OL segment. Subjects who enter the RW segment will be randomized 1:1 to either continue solriamfetol or switch to placebo for up to 24 weeks of double-blind treatment, followed by a return to open-label solriamfetol in the OLR segment. The overall duration of study treatment is up to 77 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 56 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of the treatment period in Study SOL-BED-301.
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: Solriamfetol
- Up to 52 weeks in the combined open-label and open-label return segments;
- Up to 24 weeks in the double-blind randomized withdrawal segment
干预措施: Solriamfetol (Drug)
Placebo
Up to 24 weeks in the double-blind randomized withdrawal segment
干预措施: Placebo (Drug)
结局指标
主要结局
Long-term Safety
时间窗: Up to 52 weeks.
Incidence of treatment-emergent adverse events following dosing with solriamfetol
Time from randomization to relapse of binge eating in the RW segment
时间窗: Up to 24 weeks
次要结局
未报告次要终点