FibromyalgiaPhase 4NCT04488926
Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients
A Phase 4 study testing micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) microgranules, Standard Therapy and Rescue Drug in people with Fibromyalgia, run by Epitech Group SpA at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) microgranules, Standard Therapy and Rescue Drug
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteItaly
- Study dates
- 16 Jul 2020to 2 May 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Anestesia e Rianimazione B - Azienda Ospedaliera Universitaria Integrata di Verona
Verona, VR, 37126
About this study
Official title: Efficacy and Tolerability of Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients: A Double-blind, Randomized, Placebo-controlled Clinical Trial
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.
- Conditions
- Fibromyalgia
- Being tested
- micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) microgranules, Placebo microgranules 1800mg, Standard Therapy, Rescue Drug
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) microgranulesDietary supplement
Also called Normast® MPS microgranules
Micronized and ultra-micronized Palmitoylethanolamide is on the market in Italy as a Food for Special Medical Purposes
Placebo microgranules 1800mgOther
Placebo was prepared to be indistinguishable from color and flavor from the Product
Standard TherapyDrug
(antidepressants, anticonvulsants, muscle relaxants, weak opiates, etc..) consolidated for at least 3 months
Rescue DrugDrug
Also called Paracetamol or Fans
Use as needed allowed
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Normast® MPS (mPEA and umPEA 300mg + 600mg) microgranules for sublingual use, 1800mg/die in 2 doses (morning and evening) for 90 days Receives: Dietary Supplement: micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) microgranules; Drug: Standard Therapy; Drug: Rescue Drug |
| Group 2 | Placebo comparator | Placebo microgranules for sublingual use, 1800mg/die in 2 doses (morning and evening) for 90 days Receives: Other: Placebo microgranules 1800mg; Drug: Standard Therapy; Drug: Rescue Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia symptoms assessed by Fibromyalgia Impact Questionnaire Revised
Change of Fibromyalgia symptoms
Measured: 90 days
Secondary outcomes (6)
Pain Intensity assessed by Visual Analogue Scale
Change of Visual Analogue Scale every 30 days (0: no pain - 100 mm: maximum pain)
Measured: 90 days
Health assessed by Short form-12 Health Survey
Change in Health at the end of treatment
Measured: 90 days
Sleep Disorders assessed by Pittsburgh Sleep Quality Index
Change in sleep disorders at the end of treatment
Measured: 90 days
Rescue Drugs consumption assessed by a daily diary
Change in rescue drugs consumption during the entire period
Measured: 90 days
Incidence of Adverse Events
Monitoring of adverse event
Measured: 90 days
Blood test
Clinically significant changes in blood test
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start16 Jul 2020
- Primary completion2 May 2022
- Study completion2 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epitech Group SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Azienda Ospedaliera Universitaria Integrata Verona
- Responsible party
- Sponsor
- Investigators
- Enrico Polati, MD, Principal investigator, Azienda Ospedaliera Universitaria Integrata di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488926
- Sponsor's protocol ID
- MPS-FM
- Status last verified
- Feb 2023
- First submitted
- 20 Jul 2020
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30827269
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients: A Double-blind, Randomized, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04488926
- Acronym / sponsor ID
- MPS-FM
- Conditions
- Fibromyalgia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Epitech Group SpAIndustry (pharma, biotech, devices)
- Collaborators
- Azienda Ospedaliera Universitaria Integrata Verona
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 2 May 2022 (actual)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Dietary Supplement: micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) microgranules, Drug: Standard Therapy, Drug: Rescue DrugNormast® MPS (mPEA and umPEA 300mg + 600mg) microgranules for sublingual use, 1800mg/die in 2 doses (morning and evening) for 90 days |
| Group 2 | Placebo comparator | Other: Placebo microgranules 1800mg, Drug: Standard Therapy, Drug: Rescue DrugPlacebo microgranules for sublingual use, 1800mg/die in 2 doses (morning and evening) for 90 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) microgranulesAlso: Normast® MPS microgranulesMicronized and ultra-micronized Palmitoylethanolamide is on the market in Italy as a Food for Special Medical Purposes | Dietary supplement | Group 1 |
| Placebo microgranules 1800mgPlacebo was prepared to be indistinguishable from color and flavor from the Product | Other | Group 2 |
| Standard Therapy(antidepressants, anticonvulsants, muscle relaxants, weak opiates, etc..) consolidated for at least 3 months | Drug | Group 1, Group 2 |
| Rescue DrugAlso: Paracetamol or FansUse as needed allowed | Drug | Group 1, Group 2 |
Primary outcome
Fibromyalgia symptoms assessed by Fibromyalgia Impact Questionnaire Revised
Time frame: 90 days
Change of Fibromyalgia symptoms
6 secondary outcomes
Pain Intensity assessed by Visual Analogue Scale
Time frame: 90 days
Health assessed by Short form-12 Health Survey
Time frame: 90 days
Sleep Disorders assessed by Pittsburgh Sleep Quality Index
Time frame: 90 days
Rescue Drugs consumption assessed by a daily diary
Time frame: 90 days
Incidence of Adverse Events
Time frame: 90 days
Blood test
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Background: PubMed 30827269Schweiger 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrico Polati, MD principal investigator
Azienda Ospedaliera Universitaria Integrata di Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) microgranules, Standard Therapy and Rescue Drug in people with Fibromyalgia, run by Epitech Group SpA at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia symptoms assessed by Fibromyalgia Impact Questionnaire Revised (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04488926, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.