Low Dose Naltrexone for the Treatment of Juvenile Primary Fibromyalgia Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Overall Fibromyalgia Symptom report
研究概览
简要总结
The purpose of this research is to obtain data or information on the safety and effectiveness of low dose naltrexone (LDN) for treating the symptoms of juvenile primary fibromyalgia syndrome. This is a dose finding study to find whether LDN helps the symptoms of juvenile fibromyalgia, and at what dose it does so.
详细描述
In this pilot dosage-finding and efficacy study, we will experimentally test whether LDN reduces the symptoms of JPFS. We will recruit 40 children with JPFS. Participants will be screened via the JPFS criteria of Yunus and Masi. The study will be an open-label test of various doses of LDN to determine whether LDN reduces JPFS symptoms, and the appropriate dose at which it does so. Primary endpoints will be daily pain, fatigue, and sleep.
The protocol is designed to take 18 weeks. There are a total of 10 study visits, taking place approximately every 2 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Generalized musculoskeletal aching for over 3 months duration
- •Moderate-severe pain in 5 of 11 tender points
- •Male or female
排除标准
- •Diagnosed rheumatic or autoimmune condition contributing to pain
- •Abnormal laboratory results (Rf, ANA, ESR)
- •Use of opioid analgesics in the last 6 months
- •Severe depression and/or anxiety as evidenced by a diagnosis of either disorder, or by evidence based on a clinical interview with the patient and parent at the time of screening.
- •Current or previous psychiatric disorder requiring hospitalization
- •Inability to operate Palm OS® handheld device for self-reports
- •Inability to understand English
- •Inability to attend sessions at Stanford lab every 3 weeks
- •Pregnancy or planned pregnancy, or breastfeeding
- •Abnormal liver functioning tests
结局指标
主要结局
Overall Fibromyalgia Symptom report
时间窗: duration of trial
Self Reported Pain
时间窗: duration of trial
Self-reported fatigue
时间窗: duration of trial
次要结局
未报告次要终点
研究者
Sean Mackey
Principal Investigator
Stanford University