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Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients

NCT04488926 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2023-09-07

No results posted yet for this study

Summary

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.

Conditions

  • Fibromyalgia

Interventions

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

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

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Integrata Verona

    collaborator OTHER

  • Epitech Group SpA

    lead INDUSTRY

Principal Investigators

  • Enrico Polati, MD · Azienda Ospedaliera Universitaria Integrata di Verona

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-16
Primary Completion
2022-05-02
Completion
2022-05-02

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04488926 on ClinicalTrials.gov