NCT01850420已完成2 期
A Double-Blinded, Randomized, Placebo-Controlled, Proof of Concept Phase 2a Study Exploring the Safety and Efficacy of IMC-1 for the Treatment of Patients With Fibromyalgia
Innovative Med Concepts, LLC1 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2013年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Change in pain from baseline
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, 16-week study designed to evaluate the hypothesis that tissue-resident herpes virus may be causally related to fibromyalgia symptoms or recurrence. IMC-1 is a combination treatment that is designed to suppress this suspected virus and thus alleviate fibromyalgia symptoms.
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)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of fibromyalgia
- •English speaker
排除标准
- •Rheumatologic diseases
- •Bipolar disease, OCD, severe anxiety, schizophrenia
- •Systemic infection, severe cardiac disease, chronic steroid usage
- •chronic opioid usage
研究组 & 干预措施
IMC-1
Experimental
Experimental intervention
干预措施: IMC-1 (Drug)
结局指标
主要结局
Change in pain from baseline
时间窗: 16 weeks
Comparison of the change from baseline in patient self reported pain scores between IMC-1 and placebo treatment, over 16 weeks of treatment
次要结局
- Patient Global Impression of Change(16 weeks)
- Fibromyalgia Impact Questionnaire(16 weeks)
研究者
研究点 (1)
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