Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04488926
Status:
COMPLETED
Last Update Posted:
2023-09-07
First Post:
2020-07-20
Brief Title:
Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients
Sponsor:
Epitech Group SpA
Organization:
Epitech Group SpA
Study Overview
Official Title:
Efficacy and Tolerability of Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients A Double-blind Randomized Placebo-controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None