A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Aptinyx
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Change in the Mean Numerical Rating Scale (NRS) Score
研究概览
简要总结
To evaluate the efficacy of NYX-2925 versus placebo for the treatment of fibromyalgia.
详细描述
This is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of NYX-2925 in subjects with fibromyalgia.
This 13- to 16-week study will include a 1- to 4-week Screening Period followed by a 12-week double-blind, randomized, placebo-controlled Treatment Period.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Randomization algorithm, randomization allocation, allocation to study drug or placebo.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Pain due to other conditions or diseases that would complicate participation in the study or pain reporting
- •Current or historical serious medical conditions
- •Prior participation in NYX-2925 clinical trial
研究组 & 干预措施
NYX-2925 50 mg
NYX-2925 50 mg administered orally.
干预措施: NYX-2925 (Drug)
NYX-2925 100 mg
NYX-2925 100 mg administered orally.
干预措施: NYX-2925 (Drug)
Placebo
Placebo administered orally.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the Mean Numerical Rating Scale (NRS) Score
时间窗: Week 12
Change from baseline to Week 12 in the weekly mean of the daily Numerical Rating Scale (NRS) score assessing average pain intensity in the past 24 hours, scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain)
次要结局
- Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Sleep Disturbance Score(Week 12)
- Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Fatigue Profile Score(Week 12)
- Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Physical Function Score(Week 12)
- Use of Rescue Medication(Week 12)
- Number of Subjects "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGI-C) at Week 12(Week 12)
- Number of Subjects Achieving ≥30% Pain Reduction(Week 12)
- Fibromyalgia Impact Questionnaire-Revised (FIQR) Score(Week 12)
- Daily Sleep Interference (DSIS) Score(Week 12)
- Number of Subjects Achieving ≥50% Pain Reduction(Week 12)