Effect of Milnacipran on Pain Processing and Functional Magnetic Resonance Imaging (fMRI) Activation Patterns in Patients With Fibromyalgia
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in Medium Pressure Pain Threshold From Baseline to End of Treatment.
研究概览
简要总结
The purpose of this study is to evaluate the effect of milnacipran on how the brain processes pain in patients with fibromyalgia and to assess the relationship between this effect and brain activation patterns during functional magnetic resonance imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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 defined by 1990 American College of Rheumatology (ACR) criteria
- •Visual analog pain score between 40 and 90 mm
- •Right-hand dominance
排除标准
- •Suicidal risk
- •Substance Abuse
- •Pulmonary dysfunction
- •Renal impairment
- •Active cardiac disease
- •Autoimmune disease
- •Uncontrolled narrow-angle glaucoma
- •Active liver disease
- •Active peptic ulcer disease or a history of inflammatory bowel disease or celiac sprue
- •Unstable endocrine disease
- •Prostatic enlargement
研究组 & 干预措施
1
Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
干预措施: Placebo (Drug)
2
Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
干预措施: Placebo (Drug)
1
Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
干预措施: Milnacipran (Drug)
2
Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
干预措施: Milnacipran (Drug)
结局指标
主要结局
Change in Medium Pressure Pain Threshold From Baseline to End of Treatment.
时间窗: Week 0, 5, 7 and 12
Pain intensity is rated using the Gracely Box Scale, where 0 is no pain sensation and 20 is extremely intense. Painful blunt pressure is applied to the thumbnail of the patient's left hand. A software system will determine medium(rated as 7 or 8) and high pain (rated as 13 or 14) thresholds at baseline, week 5 and at a second baseline at week 7 and week 12.
次要结局
- Change in Diffuse Noxious Inhibitory Control (DNIC) Effect From Baseline to End of Treatment.(Weeks 0, 5, 7 and 12)