Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients

Phase 4

Completed

• Conditions: Fibromyalgia
• Interventions: Other: Placebo microgranules 1800mg; Dietary Supplement: micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) microgranules; Drug: Standard Therapy; Drug: Rescue Drug

• Registration Number: NCT04488926
• Lead Sponsor: Epitech Group SpA

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-16
• Study First Submitted: 2020-07-20
• Study First Submitted QC: 2020-07-24
• Study First Posted: 2020-07-28
• Primary Completion: 2022-05-02
• Study Completion: 2022-05-02
• Status Verified: 2023-02
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Standard Therapy	Placebo microgranules for sublingual use, 1800mg/die in 2 doses (morning and evening) for 90 days
Group 2	Placebo microgranules 1800mg	Placebo microgranules for sublingual use, 1800mg/die in 2 doses (morning and evening) for 90 days
Group 1	micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) microgranules	Normast® MPS (mPEA and umPEA 300mg + 600mg) microgranules for sublingual use, 1800mg/die in 2 doses (morning and evening) for 90 days
Group 1	Rescue Drug	Normast® MPS (mPEA and umPEA 300mg + 600mg) microgranules for sublingual use, 1800mg/die in 2 doses (morning and evening) for 90 days
Group 1	Standard Therapy	Normast® MPS (mPEA and umPEA 300mg + 600mg) microgranules for sublingual use, 1800mg/die in 2 doses (morning and evening) for 90 days
Group 2	Rescue Drug	Placebo microgranules for sublingual use, 1800mg/die in 2 doses (morning and evening) for 90 days

Primary Outcome Measures

Name	Time	Method
Fibromyalgia symptoms assessed by Fibromyalgia Impact Questionnaire Revised	90 days	Change of Fibromyalgia symptoms

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Anestesia e Rianimazione B - Azienda Ospedaliera Universitaria Integrata di Verona; 🇮🇹 Verona, VR, Italy