Clinical trial NCT04488926: Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients
Official title: Efficacy and Tolerability of Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients: A Double-blind, Randomized, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fibromyalgia
Lead sponsor: Epitech Group SpA
Sponsor class: INDUSTRY
Collaborators: name: Azienda Ospedaliera Universitaria Integrata Verona
First posted: 2020-07-28
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Fibromyalgia symptoms assessed by Fibromyalgia Impact Questionnaire Revised
timeFrame: 90 days
Secondary outcomes:
measure: Pain Intensity assessed by Visual Analogue Scale
timeFrame: 90 days
measure: Health assessed by Short form-12 Health Survey
timeFrame: 90 days
measure: Sleep Disorders assessed by Pittsburgh Sleep Quality Index
timeFrame: 90 days
measure: Rescue Drugs consumption assessed by a daily diary
timeFrame: 90 days
measure: Incidence of Adverse Events
timeFrame: 90 days
measure: Blood test
timeFrame: 90 days
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Anestesia e Rianimazione B - Azienda Ospedaliera Universitaria Integrata di Verona
state: VR
Study officials:
affiliation: Azienda Ospedaliera Universitaria Integrata di Verona
name: Enrico Polati, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.