Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

July 16, 2020

Primary Completion Date

May 2, 2022

Study Completion Date

May 2, 2022

Conditions
Fibromyalgia
Interventions
DIETARY_SUPPLEMENT

micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) microgranules

Micronized and ultra-micronized Palmitoylethanolamide is on the market in Italy as a Food for Special Medical Purposes

OTHER

Placebo microgranules 1800mg

Placebo was prepared to be indistinguishable from color and flavor from the Product

DRUG

Standard Therapy

(antidepressants, anticonvulsants, muscle relaxants, weak opiates, etc..) consolidated for at least 3 months

DRUG

Rescue Drug

Use as needed allowed

Trial Locations (1)

37126

Anestesia e Rianimazione B - Azienda Ospedaliera Universitaria Integrata di Verona, Verona

All Listed Sponsors
collaborator

Azienda Ospedaliera Universitaria Integrata Verona

OTHER

lead

Epitech Group SpA

INDUSTRY

NCT04488926 - Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients | Biotech Hunter | Biotech Hunter