Fibromyalgia Clinical Trial
Official title:
Efficacy and Tolerability of Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients: A Double-blind, Randomized, Placebo-controlled Clinical Trial
NCT number | NCT04488926 |
Other study ID # | MPS-FM |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | July 16, 2020 |
Est. completion date | May 2, 2022 |
Verified date | February 2023 |
Source | Epitech Group SpA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | May 2, 2022 |
Est. primary completion date | May 2, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Anestesia e Rianimazione B - Azienda Ospedaliera Universitaria Integrata di Verona | Verona | VR |
Lead Sponsor | Collaborator |
---|---|
Epitech Group SpA | Azienda Ospedaliera Universitaria Integrata Verona |
Italy,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fibromyalgia symptoms assessed by Fibromyalgia Impact Questionnaire Revised | Change of Fibromyalgia symptoms | 90 days | |
Secondary | Pain Intensity assessed by Visual Analogue Scale | Change of Visual Analogue Scale every 30 days (0: no pain - 100 mm: maximum pain) | 90 days | |
Secondary | Health assessed by Short form-12 Health Survey | Change in Health at the end of treatment | 90 days | |
Secondary | Sleep Disorders assessed by Pittsburgh Sleep Quality Index | Change in sleep disorders at the end of treatment | 90 days | |
Secondary | Rescue Drugs consumption assessed by a daily diary | Change in rescue drugs consumption during the entire period | 90 days | |
Secondary | Incidence of Adverse Events | Monitoring of adverse event | 90 days | |
Secondary | Blood test | Clinically significant changes in blood test | 90 days |
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