An Open-Label Pilot Study to Assess Potential Mechanisms for Fibromyalgia in Peripheral Tissue Innervation That Could Predict Therapeutic Responsiveness to Milnacipran
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Efficacy of milnacipran will be determined by neurological and pain assessments
研究概览
简要总结
The purpose of this study is to examine the characteristics of the nerves and the small veins in the skin of people with fibromyalgia. This information will then be used to identify possible processes in the skin that may help explain why some people feel pain relief with the study drug (milnacipran) and others do not. The investigators expect to learn more about the pathophysiology of fibromyalgia and the way in which milnacipran acts on these patients. The investigators hypotheses are:
- The pathophysiologic basis of fibromyalgia in some patients may be due to a biochemical and/or morphological pathology among the sensory innervation.
- Fibromyalgia patients may have different sites of innervation.
- Milnacipran may have a therapeutic effect on some fibromyalgia patients.
- Abnormalities in fibromyalgia patients may predict the likelihood of a good response to milnacipran.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female age 18-70
- •fulfill the ACR criteria for FMA (wide spread pain for a least 3 months and pain in at least 11 or 18 tender point sites.
- •VAS score greater that 40mm at Screening and Randomization visits.
排除标准
- •History of clinically significant liver disease, serious peripheral vascular disease, a blood clotting disorder, or any other medical condition felt to be exclusionary by the investigator.
- •Allergy to lidocaine
- •Unwillingness to sign informed consent or any other reasons for which the investigator feels the subject cannot complete the study
- •Women who are pregnant, breastfeeding or trying to become pregnant
- •Active cancer with the previous two years except treated basal cell carcinoma of the skin.
- •presence of dermatological or neurological condition that could interfere with the interpretation of the skin biopsy or QST
- •Co-existing conditions that can produce chronic widespread pain
- •Presence of uncontrolled or severe depression
- •Patients with Worker's Compensation, pending Worker's Compensation,
- •any ongoing litigation or disability claims due to fibromyalgia or any other source of pain, or currently receiving monetary compensation as a result of any of the above.
- •presence of uncontrolled narrow-angle glaucoma
研究组 & 干预措施
Subjects with Fibromyalgia
Subjects with Fibromyalgia have skin biopsies taken from the dominant trapezius and palm. Subjects will receive an eight week supply of milnacipran to be titrated 12.5 mg x one day, 12.5 mg twice a day x 2 days, 25mg twice daily for 4 days, then 50mg twice a day x 7 weeks.
干预措施: Milnacipran (Drug)
Subjects with Fibromyalgia
Subjects with Fibromyalgia have skin biopsies taken from the dominant trapezius and palm. Subjects will receive an eight week supply of milnacipran to be titrated 12.5 mg x one day, 12.5 mg twice a day x 2 days, 25mg twice daily for 4 days, then 50mg twice a day x 7 weeks.
干预措施: Skin Biopsy (Procedure)
Control subjects without Fibromyalgia
Subjects without Fibromyalgia have skin biopsies taken from the dominant trapezius and palm.
干预措施: Skin Biopsy (Procedure)
结局指标
主要结局
Efficacy of milnacipran will be determined by neurological and pain assessments
时间窗: 10 weeks
Patients will be evaluated prior to being started on milnacipran and again after 8 weeks. We will use data from VAS scores, sleep diaries and quantitative sensory testing.
次要结局
未报告次要终点
研究者
Charles Argoff
Principal Investigator
Albany Medical College