NCT04748705已完成2 期
A Double-Blinded, Randomized, Placebo-Controlled, Phase 2B Trial of IMC-1 for the Treatment of Fibromyalgia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 422
- 试验地点
- 2
- 主要终点
- Mean Pain Score
研究概览
简要总结
Randomized, double-blind, placebo-controlled, 16-week study designed to explore the safety and efficacy of IMC-1 for the treatment of patients with fibromyalgia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patient is female, 18 to 65 years of age, inclusive.
- •The patient has a diagnosis of primary FM as defined by the 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria (American College of Rheumatology Preliminary Diagnostic Criteria)
- •The in clinic 7-day recall VAS scale average daily pain intensity score at Screening visit within protocol defined range.
排除标准
- •Any underlying medical or psychiatric condition that could impact their safe participation per protocol.
研究组 & 干预措施
IMC-1 Oral Tablet
Experimental
2X IMC-1 Tablet taken orally, each morning and evening.
干预措施: IMC-1 (Drug)
Placebo
Placebo Comparator
2X Placebo Tablet taken orally, each morning and evening.
干预措施: Placebo BID Tablet (Drug)
结局指标
主要结局
Mean Pain Score
时间窗: 16 Week
Change from Baseline to Week 16 endpoint in the diary Numerical Rating Scale (NRS) weekly average of daily self-reported average pain severity scores. Scores range from 0 to 10 where a higher score means worse outcome.
次要结局
未报告次要终点
研究者
研究点 (2)
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