NCT07637162Enrolling By Invitation3 期
An Open-Label Study to Assess the Long-Term Safety and Efficacy of AXS-14 in the Management of Fibromyalgia
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 300
- 试验地点
- 32
研究概览
简要总结
This is a Phase 3, multi-center, 52-week, open-label trial to evaluate the long-term safety and efficacy of AXS-14 in the management of fibromyalgia.
详细描述
Eligible subjects will have previously participated in the AXS-14-FM-301 (FORWARD) study. Subjects in this open-label extension trial will receive open-label AXS-14 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in AXS-14-FM-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
AXS-14 (esreboxetine)
Experimental
Up to 52 weeks.
干预措施: AXS-14 (esreboxetine) (Drug)
研究者
研究点 (32)
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