Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04488926
• Other study ID #: MPS-FM
• Status: Completed
• Phase: Phase 4
• Start date: July 16, 2020
• Est. completion date: May 2, 2022

Study information

• Verified date: February 2023
• Source: Epitech Group SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 2, 2022
• Est. primary completion date: May 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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
• Rescue Drug
Use as needed allowed

Locations

Country	Name	City	State
Italy	Anestesia e Rianimazione B - Azienda Ospedaliera Universitaria Integrata di Verona	Verona	VR

Sponsors (2)

Lead Sponsor	Collaborator
Epitech Group SpA	Azienda Ospedaliera Universitaria Integrata Verona

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Schweiger V, Martini A, Bellamoli P, Donadello K, Schievano C, Balzo GD, Sarzi-Puttini P, Parolini M, Polati E. Ultramicronized Palmitoylethanolamide (um-PEA) as Add-on Treatment in Fibromyalgia Syndrome (FMS): Retrospective Observational Study on 407 Patients. CNS Neurol Disord Drug Targets. 2019;18(4):326-333. doi: 10.2174/1871527318666190227205359. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibromyalgia symptoms assessed by Fibromyalgia Impact Questionnaire Revised	Change of Fibromyalgia symptoms	90 days
Secondary	Pain Intensity assessed by Visual Analogue Scale	Change of Visual Analogue Scale every 30 days (0: no pain - 100 mm: maximum pain)	90 days
Secondary	Health assessed by Short form-12 Health Survey	Change in Health at the end of treatment	90 days
Secondary	Sleep Disorders assessed by Pittsburgh Sleep Quality Index	Change in sleep disorders at the end of treatment	90 days
Secondary	Rescue Drugs consumption assessed by a daily diary	Change in rescue drugs consumption during the entire period	90 days
Secondary	Incidence of Adverse Events	Monitoring of adverse event	90 days
Secondary	Blood test	Clinically significant changes in blood test	90 days

External Links

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