An interventional study of Flavonoids, DHA, EPA and placebo compound in Muscular Dystrophies and Muscle Inflammation, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Completed at 1 site in Italy. Open to participants aged 9 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-10-25.
Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Not applicable, Interventional, and Treatment
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Among 31 studies in Muscular Dystrophies with a site in Italy — 6 open to participants now, 10 under way, 1 of them phase 3. Muscular Dystrophies · Italy.
Among the 31 studies in Muscular Dystrophies with a site in Italy, this one is the 18th largest by enrollment of the 24 interventional ones that give a count, is the only one that started in 2016, is one of 9 with no phase, and was the 13th registered.
224 studies on the registry are indexed under Muscular Dystrophies; 48 are open to participants now.
Browse Muscular Dystrophies studies →6 of the 31 studies in Muscular Dystrophies with a site in Italy are open now. Recruiting first, the newest first:
Avidity Biosciences, Inc. · Sites in Italy, Australia, Belgium and 7 more countries
Ages 7–16 · Men only
Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato · Sites in Italy
Ages 6–18
University of Pavia · Sites in Italy
Ages 18–50 · Healthy volunteers
Universita di Verona · Sites in Italy
Ages 16–65
IRCCS Eugenio Medea · Sites in Italy
Ages 18+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 38 Muscular Dystrophies studies recruiting now, 14 (37%) set no upper age limit and 15 (39%) stop at 75 or younger; 24 take children under 18; 7 take healthy volunteers.
This study: 9 Years to 70 Years · all sexes · no healthy volunteers.
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31 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 5 · Phase 3 10
First in 2005; this study’s year is marked. 1 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 29 is close to the median of 30 across 140 interventional studies indexed under Muscular Dystrophies.
Median enrollment 56 across the 24 interventional studies, 200 across the 7 observational. Of the 20 that completed or were terminated, 10 (50%) have results posted.
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14 of 31 have an industry lead sponsor. The 10 most frequent:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 234 studies on the registry; 78 are open to participants now.
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico has 1 study filed under Muscular Dystrophies — fewer than ten, so there is no comparison to draw.
4 of the studies in Muscular Dystrophies with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07580365Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero AvanzatoVirtualPark_Pediatric | 2026-12 |
| NCT06666816IRCCS Eugenio MedeaObservational Study to Observe Variations of Gait Parameters in Patients With Neuromuscular Diseases | 2026-12 |
| NCT06185764Vertex Pharmaceuticals IncorporatedA Phase 1/2 Study of VX-670 in Adult Participants With Myotonic Dystrophy 1 (DM1) | 2027-02-02 |
| NCT07129954Universita di VeronaFear of Falling in Muscular Dystrophy | 2027-08-01 |
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Among the 31 studies in Muscular Dystrophies with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The study aimed to assess the safety and, partially, the efficacy of dietary supplementation of a flavonoids-, DHA- and EPA-based natural supplement in non-ambulant DMD boys and in a cohort of LGMD and FSHD patients to compare its effect in MDs of different aetiology and to eventually highlight any differences in inflammatory involved pathways. To assess safety, patient's laboratory parameters were monitored and adverse events recorded, while efficacy was evaluated through performance scale questionnaire and strength measurement (6 minute walking test and Biodex System 4 Dynamometer parameter evaluation). This study was conceived as proof of principle for the safe use of flavonoids/omega3s-based compound as an adjuvant in the management of neuromuscular disorders; besides, its efficacy in alleviating symptoms linked to secondary effects of genetic mutation as inflammation, muscular pain and weakness was assessed.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
EXCLUSION CRITERIA
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
oral administration of flavonoids, DHA and EPA, once a day for 24 weeks.
Dietary Supplement: Flavonoids, DHA, EPA
oral administration of placebo compound, once a day for 24 weeks.
Dietary Supplement: placebo compound
Drug pages: Flavonoids · Eicosapentaenoic Acid
oral administration
oral administration
Safety of the administered supplements
blood tests, to monitor any possible change before and after the study
Time frame: month 0 and month +6
Safety of the administered supplements
ECG, to monitor any possible change before and after the study
Time frame: month 0 and month +6
Safety of the administered supplements
neurological clinical assessment, to monitor any possible change before and after the study
Time frame: month 0 and month +6
Efficacy outcome - functional changes after the treatment
Biodex System 4 Dynamometer for quantitative measures (muscle strength and resistance)
Time frame: month 0 and month +6
Efficacy outcome - functional changes after the treatment
6 Minute Walking Test for quantitative measures (muscle strength and resistance)
Time frame: month 0 and month +6
Efficacy outcome - functional changes after the treatment
EK (Egen Klassifikation) scale to assess funtionality of patients with significative impairments. Min. score: 0 - max. score 30
Time frame: month 0, month +2, month +4, month +6
Efficacy outcome - functional changes after the treatment
ACTIVLIM (Activity Limitation) scale. The scale measures activity limitations for patients with upper and/or lower limb impairments and has been validated in patients affected by neuromuscular disorders. Min. score: 0 - max. score 36
Time frame: month 0, month +2, month +4, month +6
Efficacy outcome - functional changes after the treatment
ABILHAND (manual ability for adults with upper limb impairments) scale. The scale measures manual ability for adults with upper limb impairments.Min. score: 0 - max. score 36
Time frame: month 0, month +2, month +4, month +6
Ran from Feb 2016 to primary completion in Dec 2016, 10 months.
Of 46 non-industry interventional studies with no phase under Muscular Dystrophies, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 59. This study's 10 months is below that.
Counting every sponsor, half of 48 studies reached it within 33 months; a quarter within 11 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Flavonoids · Eicosapentaenoic Acid
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico →