| NCT ID | NCT07543016 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pavia |
| Condition | FSH Muscular Dystrophy |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2026-04-08 |
| Primary Completion | 2028-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2026-04-08 with a primary completion date of 2028-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Subjects of both sexes with a diagnosis of FSHD, confirmed by genetic testing. 2. Age between 18 and 50 years. 3. 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 girdle. 4. Clinical score ranging from 2 to 5. 5. Preserved ability to walk at the time of enrollment. 6. Absence of central or peripheral nervous system involvement based on neurological history and physical examination. 7. Absence of scoliosis, limb contractures, and tendon retractions. Exclusion Criteria: 1. Use of beta-blocker medications; 2. Psychological or psychiatric disorders; 3. Musculoskeletal injuries that impair the ability to perform physical exercise; 4. Recent medication adjustment, use of drugs that may affect fatigue, or use of fatigue-stimulating agents (e.g., Modafinil, amantadine); 5. Ongoing participation in another clinical investigation involving a medical device or drug, or participation in such a study completed less than 30 days prior; 6. Pregnant or breastfeeding women; 7. Patients unable to understand the purpose and conditions of the study and unable to provide informed consent; 8. Presence of additional diseases that may interfere with measurements; 9. Patients deprived of liberty or under legal guardianship. Healthy participants will be age- and sex-matched adults without neuromuscular disease: 1. no chronic disease; 2. no neuromuscular disorders; 3. Same age range.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07543016 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying FSH Muscular Dystrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07543016 currently recruiting?
Yes, NCT07543016 is actively recruiting participants. Contact the research team at giuseppe.dantona@unipv.it for enrollment information.
Where is the NCT07543016 trial being conducted?
This trial is being conducted at Voghera, Italy.
Who is sponsoring the NCT07543016 clinical trial?
NCT07543016 is sponsored by University of Pavia. The trial plans to enroll 48 participants.