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Trial record 69 of 215 for:    Inflammatory Myopathies

Safety and Efficacy of a Flavonoids- and omega3s-based Compound for the Treatment of Muscular Dystrophies (PRO1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03317171
Recruitment Status : Completed
First Posted : October 23, 2017
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Muscular Dystrophies Muscle Inflammation Dietary Supplement: Flavonoids, DHA, EPA Dietary Supplement: placebo compound Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Studio Monocentrico in Doppio Cieco Randomizzato Dell'Effetto di Una Miscela di Flavonoidi ed Acidi Grassi Naturali in Pazienti Affetti da Distrofia Muscolare
Actual Study Start Date : February 28, 2016
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016


Arm Intervention/treatment
Experimental: Treated group
oral administration of flavonoids, DHA and EPA, once a day for 24 weeks.
Dietary Supplement: Flavonoids, DHA, EPA
oral administration

Placebo Comparator: Placebo group
oral administration of placebo compound, once a day for 24 weeks.
Dietary Supplement: placebo compound
oral administration




Primary Outcome Measures :
  1. Safety of the administered supplements [ Time Frame: month 0 and month +6 ]
    blood tests, to monitor any possible change before and after the study

  2. Safety of the administered supplements [ Time Frame: month 0 and month +6 ]
    ECG, to monitor any possible change before and after the study

  3. Safety of the administered supplements [ Time Frame: month 0 and month +6 ]
    neurological clinical assessment, to monitor any possible change before and after the study


Secondary Outcome Measures :
  1. Efficacy outcome - functional changes after the treatment [ Time Frame: month 0 and month +6 ]
    Biodex System 4 Dynamometer for quantitative measures (muscle strength and resistance)

  2. Efficacy outcome - functional changes after the treatment [ Time Frame: month 0 and month +6 ]
    6 Minute Walking Test for quantitative measures (muscle strength and resistance)

  3. Efficacy outcome - functional changes after the treatment [ Time Frame: month 0, month +2, month +4, month +6 ]
    EK (Egen Klassifikation) scale to assess funtionality of patients with significative impairments. Min. score: 0 - max. score 30

  4. Efficacy outcome - functional changes after the treatment [ Time Frame: month 0, month +2, month +4, month +6 ]
    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

  5. Efficacy outcome - functional changes after the treatment [ Time Frame: month 0, month +2, month +4, month +6 ]
    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



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Ages Eligible for Study:   9 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   males, for patients affected by Duchenne muscular dystrophy
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  • documented genetic and histological diagnosis of DMD, FSHD and LGMD;
  • absence of severe cardiac and pulmonary disease;
  • age superior to 9 years for DMD, between 9 and 70 years for LGMD and between 20 and 70 years for FSHD;
  • glucocorticosteroid treatment for 6 or more months (stable dose and regimen for ≥3 months before screening) and for the duration of the study;
  • adhesion to inform consent by same patients or parents/tutors for minors.

EXCLUSION CRITERIA

  • severe cardiac and pulmonary disease;
  • positive hepatitis B surface antigen (HBsAg) test, positive hepatitis C and HIV tests;
  • low kidney and liver functionality;
  • autoimmune disorders;
  • mental retardation (IQ via Wechsler Intelligence Scale < 70);
  • psychological-psychiatric disorders; adverse psychosocial conditions;
  • known allergies to some of compounds to be used in the trial;
  • pathologies occurring just before or during the trial (fever, metabolic disorders, drug abuse);
  • enrollment to other trials (steroids regime won't be considered in this list)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03317171


Locations
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Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
MIlan, Italy, 20122
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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Responsible Party: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT03317171     History of Changes
Other Study ID Numbers: 1768
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
dietary supplementation
flavonoids
omega 3

Additional relevant MeSH terms:
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Inflammation
Muscular Dystrophies
Myositis
Pathologic Processes
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn