Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients

Epitech Group

Status and phase: Completed; Phase 4

Conditions: Fibromyalgia

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04488926

MPS-FM

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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21 participants in 2 patient groups, including a placebo group

Group 1

Active Comparator group

Description:

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

Treatment:

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

Drug: Rescue Drug

Drug: Standard Therapy

Group 2

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo microgranules 1800mg

Drug: Rescue Drug

Drug: Standard Therapy