NCT04488926

Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients

Completed Phase 4 Last updated 7 September 2023

What this trial tests

Phase 4 trial testing micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) microgranules in Fibromyalgia in 21 participants. Completed in 2 May 2022.

Timeline

16 July 2020

Primary endpoint
2 May 2022

2 May 2022

Quick facts

Lead sponsor	Epitech Group SpA
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	other
Enrollment	21
Start date	16 July 2020
Primary completion	2 May 2022
Estimated completion	2 May 2022
Sites	1 location across Italy

Drugs / interventions tested

• micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) microgranules
• Placebo microgranules 1800mg
• Standard Therapy — full drug profile →
• Rescue Drug — full drug profile →

Conditions studied

• Fibromyalgia — all drugs for Fibromyalgia →

Sponsor

Epitech Group SpA — full company profile →

Who can join

18 and older, any sex, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Goods and Bads of the Endocannabinoid System as a Therapeutic Target: Lessons Learned after 30 Years.
   Maccarrone M, Di Marzo V, Gertsch J, Grether U, et al · · 2023 · cited 128× · PMID 37164640 · DOI 10.1124/pharmrev.122.000600
2. Palmitoylethanolamide in the Treatment of Pain and Its Clinical Application Prospects.
   Wang Y, Duan X, Li Z, Pan Y, et al · · 2025 · PMID 40827226 · DOI 10.2147/dddt.s540327