Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-16

Study Completion Date

2022-05-02

Brief Summary

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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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Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DIETARY_SUPPLEMENT

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

Standard Therapy

Intervention Type DRUG

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

Rescue Drug

Intervention Type DRUG

Use as needed allowed

Group 2

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

Group Type PLACEBO_COMPARATOR

Placebo microgranules 1800mg

Intervention Type OTHER

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

Standard Therapy

Intervention Type DRUG

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

Rescue Drug

Intervention Type DRUG

Use as needed allowed

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Placebo microgranules 1800mg

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

Intervention Type OTHER

Standard Therapy

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

Intervention Type DRUG

Rescue Drug

Use as needed allowed

Intervention Type DRUG

Other Intervention Names

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Normast® MPS microgranules Paracetamol or Fans

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No