Efficacy and Tolerability of Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients: A Double-blind, Randomized, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Fibromyalgia symptoms assessed by Fibromyalgia Impact Questionnaire Revised
研究概览
简要总结
The onset of chronic Fibromyalgia symptomatology is due to central alterations, together with peripheral neuroimmune modifications. Using positron emission tomography (PET), it has been observed for the first time that fibromyalgia patients have a high activation of microglial cells compared to normal subjects. Experimental evidence in neuroinflammation models in vitro and in vivo have demonstrated the anti-inflammatory and neuroprotective effect of Palmitoylethanolamide (PEA), effects confirmed by observational clinical investigations conducted in patients with fibromyalgia in which micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA) reduced the intensity of pain improving the quality of life. The aim of this study is to investigate the efficacy and tolerability of PEA-m + PEA-um administered as an add-on therapy with a double-blind, randomized, placebo-controlled clinical investigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Fibromyalgia according to the criteria of the American College of Rheumatology 2016 (symptoms for at least 3 months, Widespread Pain Index (WPI) ≥ 7 and Symptom Severity (SS) ≥ 5 or WPI 4-6 and SS ≥ 9)
- •Pain intensity assessed on the Visual Analogue Scale (VAS) ≥ 40
- •PEA-naive patients
- •Patients who agree to sign informed consent
排除标准
- •Values of WPI <7 and SS <5
- •Pain intensity assessed on the Visual Analogue Scale (VAS) <40
- •Patients who have already taken PEA in the past
- •Allergic or hypersensitive subjects to the product and / or one or more of its excipients
- •Patients who refuse to sign informed consent
研究组 & 干预措施
Group 1
Normast® MPS (mPEA and umPEA 300mg + 600mg) microgranules for sublingual use, 1800mg/die in 2 doses (morning and evening) for 90 days
干预措施: micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) microgranules (Dietary Supplement)
Group 1
Normast® MPS (mPEA and umPEA 300mg + 600mg) microgranules for sublingual use, 1800mg/die in 2 doses (morning and evening) for 90 days
干预措施: Standard Therapy (Drug)
Group 1
Normast® MPS (mPEA and umPEA 300mg + 600mg) microgranules for sublingual use, 1800mg/die in 2 doses (morning and evening) for 90 days
干预措施: Rescue Drug (Drug)
Group 2
Placebo microgranules for sublingual use, 1800mg/die in 2 doses (morning and evening) for 90 days
干预措施: Placebo microgranules 1800mg (Other)
Group 2
Placebo microgranules for sublingual use, 1800mg/die in 2 doses (morning and evening) for 90 days
干预措施: Standard Therapy (Drug)
Group 2
Placebo microgranules for sublingual use, 1800mg/die in 2 doses (morning and evening) for 90 days
干预措施: Rescue Drug (Drug)
结局指标
主要结局
Fibromyalgia symptoms assessed by Fibromyalgia Impact Questionnaire Revised
时间窗: 90 days
Change of Fibromyalgia symptoms
次要结局
- Blood test(90 days)
- Rescue Drugs consumption assessed by a daily diary(90 days)
- Sleep Disorders assessed by Pittsburgh Sleep Quality Index(90 days)
- Pain Intensity assessed by Visual Analogue Scale(90 days)
- Health assessed by Short form-12 Health Survey(90 days)
- Incidence of Adverse Events(90 days)