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Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) microgranules
Placebo microgranules 1800mg
Standard Therapy
Rescue Drug
Sponsored by
Epitech Group SpA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fibromyalgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Anestesia e Rianimazione B - Azienda Ospedaliera Universitaria Integrata di Verona

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group 1

Group 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Fibromyalgia symptoms assessed by Fibromyalgia Impact Questionnaire Revised
Change of Fibromyalgia symptoms

Secondary Outcome Measures

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

Full Information

First Posted
July 20, 2020
Last Updated
September 6, 2023
Sponsor
Epitech Group SpA
Collaborators
Azienda Ospedaliera Universitaria Integrata Verona
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1. Study Identification

Unique Protocol Identification Number
NCT04488926
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 16, 2020 (Actual)
Primary Completion Date
May 2, 2022 (Actual)
Study Completion Date
May 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Epitech Group SpA
Collaborators
Azienda Ospedaliera Universitaria Integrata Verona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Normast® MPS (mPEA and umPEA 300mg + 600mg) microgranules for sublingual use, 1800mg/die in 2 doses (morning and evening) for 90 days
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
Placebo microgranules for sublingual use, 1800mg/die in 2 doses (morning and evening) for 90 days
Intervention Type
Dietary Supplement
Intervention Name(s)
micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) microgranules
Other Intervention Name(s)
Normast® MPS microgranules
Intervention Description
Micronized and ultra-micronized Palmitoylethanolamide is on the market in Italy as a Food for Special Medical Purposes
Intervention Type
Other
Intervention Name(s)
Placebo microgranules 1800mg
Intervention Description
Placebo was prepared to be indistinguishable from color and flavor from the Product
Intervention Type
Drug
Intervention Name(s)
Standard Therapy
Intervention Description
(antidepressants, anticonvulsants, muscle relaxants, weak opiates, etc..) consolidated for at least 3 months
Intervention Type
Drug
Intervention Name(s)
Rescue Drug
Other Intervention Name(s)
Paracetamol or Fans
Intervention Description
Use as needed allowed
Primary Outcome Measure Information:
Title
Fibromyalgia symptoms assessed by Fibromyalgia Impact Questionnaire Revised
Description
Change of Fibromyalgia symptoms
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Pain Intensity assessed by Visual Analogue Scale
Description
Change of Visual Analogue Scale every 30 days (0: no pain - 100 mm: maximum pain)
Time Frame
90 days
Title
Health assessed by Short form-12 Health Survey
Description
Change in Health at the end of treatment
Time Frame
90 days
Title
Sleep Disorders assessed by Pittsburgh Sleep Quality Index
Description
Change in sleep disorders at the end of treatment
Time Frame
90 days
Title
Rescue Drugs consumption assessed by a daily diary
Description
Change in rescue drugs consumption during the entire period
Time Frame
90 days
Title
Incidence of Adverse Events
Description
Monitoring of adverse event
Time Frame
90 days
Title
Blood test
Description
Clinically significant changes in blood test
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrico Polati, MD
Organizational Affiliation
Azienda Ospedaliera Universitaria Integrata di Verona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anestesia e Rianimazione B - Azienda Ospedaliera Universitaria Integrata di Verona
City
Verona
State/Province
VR
ZIP/Postal Code
37126
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
30827269
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.
Results Reference
background
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/30827269/
Description
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Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients

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