Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients

NCT04488926 | Completed Phase 4

• 1 other identifier: MPS-FM
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Fibromyalgia symptoms assessed by Fibromyalgia Impact Questionnaire Revised

  Change of Fibromyalgia symptoms

  90 days

Secondary Outcomes (6)

• Pain Intensity assessed by Visual Analogue Scale

  90 days

• Health assessed by Short form-12 Health Survey

  90 days

• Sleep Disorders assessed by Pittsburgh Sleep Quality Index

  90 days

• Rescue Drugs consumption assessed by a daily diary

  90 days

• Incidence of Adverse Events

  90 days

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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

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

Group 2

PLACEBO COMPARATOR

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

Other: Placebo microgranules 1800mg; Drug: Standard Therapy; Drug: Rescue Drug

Interventions

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

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

Also known as: Normast® MPS microgranules

Group 1

Placebo microgranules 1800mg OTHER

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

Group 2

Standard Therapy DRUG

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

Group 1; Group 2

Rescue Drug DRUG

Use as needed allowed

Also known as: Paracetamol or Fans

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Epitech Group SpA: lead
• Azienda Ospedaliera Universitaria Integrata Verona: collaborator

Study Sites (1)

Anestesia e Rianimazione B - Azienda Ospedaliera Universitaria Integrata di Verona

Verona, VR, 37126, Italy

Location

Related 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.

  PMID: 30827269 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Fibromyalgia

Interventions

Standard of Care; Drug Repositioning; Acetaminophen

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Drug Development; Investigative Techniques; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Enrico Polati, MD

  Azienda Ospedaliera Universitaria Integrata di Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 28, 2020
• Study Start: July 16, 2020
• Primary Completion: May 2, 2022
• Study Completion: May 2, 2022
• Last Updated: September 7, 2023

Record last verified: 2023-02

Locations

IT (1)