Status:
COMPLETED
Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients
Lead Sponsor:
Epitech Group SpA
Collaborating Sponsors:
Azienda Ospedaliera Universitaria Integrata Verona
Conditions:
Fibromyalgia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2022
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04488926
Start Date
July 16 2020
End Date
May 2 2022
Last Update
September 7 2023
Active Locations (1)
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1
Anestesia e Rianimazione B - Azienda Ospedaliera Universitaria Integrata di Verona
Verona, VR, Italy, 37126