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New treatment option for FSH Muscular Dystrophy
Official title Amino Acids and Exercise in FSHD
ClinicalTrials.gov ID: NCT07543016
What this study is testing
- What it's testing
- This study evaluates whether amino acid supplementation, combined with a structured diet and exercise program, improves body composition (increased muscle mass and reduced fat mass) and physical performance in individuals with facioscapulohumeral muscular dystrophy (FSHD). The study also compares responses to the intervention between individuals with FSHD and healthy individuals matched for age and sex.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- people of both sexes with a diagnosis of FSHD, confirmed by genetic testing.
- Age between 18 and 50 years.
- Belonging to clinical category A among the four defined in the Comprehensive Clinical Evaluation Form. These patients present the most characteristic...
- Clinical score ranging from 2 to 5.
- Preserved ability to walk at the time of enrollment.
You likely can't join if
- Use of beta-blocker medications;
- Psychological or psychiatric disorders;
- Musculoskeletal injuries that impair the ability to perform physical exercise;
- Recent medication adjustment, use of drugs that may affect fatigue, or use of fatigue-stimulating agents (e.g., Modafinil, amantadine);
- Ongoing participation in another clinical investigation involving a medical device or drug, or participation in such a study completed less than 30...
- Pregnant or breastfeeding women;
See the full eligibility criteria
- people of both sexes with a diagnosis of FSHD, confirmed by genetic testing.
- Age between 18 and 50 years.
- Belonging to clinical category A among the four defined in the Comprehensive Clinical Evaluation Form. These patients present the most characteristic signs of the disease: muscle weakness of the facial and scapular...
- Clinical score ranging from 2 to 5.
- Preserved ability to walk at the time of enrollment.
- Absence of central or peripheral nervous system involvement based on neurological history and physical examination.
- Absence of scoliosis, limb contractures, and tendon retractions.
- Use of beta-blocker medications;
- Psychological or psychiatric disorders;
- Musculoskeletal injuries that impair the ability to perform physical exercise;
- Recent medication adjustment, use of drugs that may affect fatigue, or use of fatigue-stimulating agents (e.g., Modafinil, amantadine);
- Ongoing participation in another clinical investigation involving a medical device or drug, or participation in such a study completed less than 30 days prior;
- Pregnant or breastfeeding women;
- Patients unable to understand the purpose and conditions of the study and unable to provide informed consent;
- Presence of additional diseases that may interfere with measurements;
- Patients deprived of liberty or under legal guardianship. Healthy participants will be age- and sex-matched adults without neuromuscular disease:
- no chronic disease;
- no neuromuscular disorders;
- Same age range.
The study team makes the final eligibility decision.
Where it's taking place
- Voghera, Pavia, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Voghera, Pavia, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.