A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy and Safety of AXS-14 in the Management of Fibromyalgia
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 620
- 试验地点
- 54
- 主要终点
- Time from randomization to loss of therapeutic response
研究概览
简要总结
The study is a Phase 3, double-blind, placebo-controlled, randomized withdrawal study to assess the efficacy and safety of AXS-14 in the management of fibromyalgia.
详细描述
This study is a multi-center trial consisting of a 12-week open-label treatment period (OLP), followed by a 12-week double-blind, placebo-controlled, randomized withdrawal period (DBRWP). During the OLP, subjects receive open-label AXS-14. Subjects achieving treatment response will be randomized into the DBRWP in a 1:1 ratio to either continue on AXS-14 or switch to placebo for up to 12 weeks or until a loss of therapeutic response occurs.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a primary diagnosis of fibromyalgia based on the 2016 ACR diagnostic criteria.
- •Male or female, ≥18 years of age.
- •Provides written informed consent to participate in the study before conducting any study procedures.
排除标准
- •Previous participation in a clinical trial with reboxetine or esreboxetine or currently receiving treatment with reboxetine for any condition.
- •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)
- Up to 12 weeks in the open-label period;
- Up to 12 weeks in the randomized double-blind period (if applicable)
干预措施: AXS-14 (Esreboxetine) (Drug)
Placebo
• Up to 12 weeks in the randomized double-blind period (if applicable)
干预措施: Placebo (Drug)
结局指标
主要结局
Time from randomization to loss of therapeutic response
时间窗: 12 Weeks
次要结局
未报告次要终点