Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients
Status:
Recruiting
Trial end date:
2021-11-01
Target enrollment:
Participant gender:
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.