Trial | NCT04488926  Report issue

Title

Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients
Efficacy and Tolerability of Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients: A Double-blind, Randomized, Placebo-controlled Clinical Trial

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    21
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.
Study Started
Jul 16
2020
Primary Completion
May 02
2022
Study Completion
May 02
2022
Last Update
Sep 07
2023

Dietary Supplement micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) microgranules

Micronized and ultra-micronized Palmitoylethanolamide is on the market in Italy as a Food for Special Medical Purposes

  • Other names: Normast® MPS microgranules

Other Placebo microgranules 1800mg

Placebo was prepared to be indistinguishable from color and flavor from the Product

Drug Standard Therapy

(antidepressants, anticonvulsants, muscle relaxants, weak opiates, etc..) consolidated for at least 3 months

Drug Rescue Drug

Use as needed allowed

  • Other names: Paracetamol or Fans

Group 1 Active Comparator

Normast® MPS (mPEA and umPEA 300mg + 600mg) microgranules for sublingual use, 1800mg/die in 2 doses (morning and evening) for 90 days

Group 2 Placebo Comparator

Placebo microgranules for sublingual use, 1800mg/die in 2 doses (morning and evening) for 90 days

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

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
No Results Posted