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OpenTrials
Completed

NCT Number: NCT04488926

Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Anestesia e Rianimazione B - Azienda Ospedaliera Universitaria Integrata di Verona

Verona, VR, 37126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Dietary Supplement

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

Other names: Normast® MPS microgranules

Placebo microgranules 1800mg

Other

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

Standard therapy

Drug

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

Rescue Drug

Drug

Use as needed allowed

Other names: Paracetamol or Fans

Primary outcomes

  1. Fibromyalgia symptoms assessed by Fibromyalgia Impact Questionnaire Revised

    Time frame: 90 days

    Change of Fibromyalgia symptoms

Secondary outcomes

  1. Pain Intensity assessed by Visual Analogue Scale

    Time frame: 90 days

    Change of Visual Analogue Scale every 30 days (0: no pain - 100 mm: maximum pain)

  2. Health assessed by Short form-12 Health Survey

    Time frame: 90 days

    Change in Health at the end of treatment

  3. Sleep Disorders assessed by Pittsburgh Sleep Quality Index

    Time frame: 90 days

    Change in sleep disorders at the end of treatment

  4. Rescue Drugs consumption assessed by a daily diary

    Time frame: 90 days

    Change in rescue drugs consumption during the entire period

  5. Incidence of Adverse Events

    Time frame: 90 days

    Monitoring of adverse event

  6. Blood test

    Time frame: 90 days

    Clinically significant changes in blood test

Sponsors and collaborators

Lead sponsor

Epitech Group SpA

Industry

Collaborators

  • Azienda Ospedaliera Universitaria Integrata Verona

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 28, 2020
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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