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Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04488926
Recruitment Status : Unknown
Verified July 2020 by Epitech Group SpA.
Recruitment status was:  Recruiting
First Posted : July 28, 2020
Last Update Posted : October 5, 2020
Sponsor:
Collaborator:
Azienda Ospedaliera Universitaria Integrata Verona
Information provided by (Responsible Party):
Epitech Group SpA

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Dietary Supplement: micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) microgranules Other: Placebo microgranules 1800mg Drug: Standard Therapy Drug: Rescue Drug Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Efficacy and Tolerability of Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients: A Double-blind, Randomized, Placebo-controlled Clinical Trial
Actual Study Start Date : July 16, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group 1
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
Micronized and ultra-micronized Palmitoylethanolamide is on the market in Italy as a Food for Special Medical Purposes
Other Name: Normast® MPS microgranules

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

Drug: Rescue Drug
Use as needed allowed
Other Name: Paracetamol or Fans
Placebo Comparator: Group 2
Placebo microgranules for sublingual use, 1800mg/die in 2 doses (morning and evening) for 90 days
 Other: Placebo microgranules 1800mg
Placebo was prepared to be indistinguishable from color and flavor from the Product

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

Drug: Rescue Drug
Use as needed allowed
Other Name: Paracetamol or Fans


Outcome Measures
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Primary Outcome Measures :
  1. Fibromyalgia symptoms assessed by Fibromyalgia Impact Questionnaire Revised [ Time Frame: 90 days ]
    Change of Fibromyalgia symptoms


Secondary Outcome Measures :
  1. Pain Intensity assessed by Visual Analogue Scale [ Time Frame: 90 days ]
    Change of Visual Analogue Scale every 30 days (0: no pain - 100 mm: maximum pain)

  2. Health assessed by Short form-12 Health Survey [ Time Frame: 90 days ]
    Change in Health at the end of treatment

  3. Sleep Disorders assessed by Pittsburgh Sleep Quality Index [ Time Frame: 90 days ]
    Change in sleep disorders at the end of treatment

  4. Rescue Drugs consumption assessed by a daily diary [ Time Frame: 90 days ]
    Change in rescue drugs consumption during the entire period

  5. Incidence of Adverse Events [ Time Frame: 90 days ]
    Monitoring of adverse event

  6. Blood test [ Time Frame: 90 days ]
    Clinically significant changes in blood test


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04488926


Contacts
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Contact: Epitech Group SpA Clinical Research +39 049 8016784 info@epitech.it

Locations
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Italy
Anestesia e Rianimazione B - Azienda Ospedaliera Universitaria Integrata di Verona Recruiting
Verona, VR, Italy, 37126
Contact: Enrico Polati, MD         
Principal Investigator: Prof. Enrico Polati, MD         
Sub-Investigator: Prof. Vittorio Schweiger, MD         
Sponsors and Collaborators
Epitech Group SpA
Azienda Ospedaliera Universitaria Integrata Verona
Investigators
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Principal Investigator: Enrico Polati, MD Azienda Ospedaliera Universitaria Integrata di Verona
More Information
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Additional Information:

Publications:

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Responsible Party: Epitech Group SpA
ClinicalTrials.gov Identifier: NCT04488926    
Other Study ID Numbers: MPS-FM
First Posted: July 28, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Palmidrol
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Antiviral Agents
Anti-Infective Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists