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Amino acid cocktail and workouts aim to boost muscle in rare disease

NCT ID NCT07543016

Symptom relief Sponsor: University of Pavia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether taking amino acid supplements, along with a special diet and exercise program, can help people with facioscapulohumeral muscular dystrophy (FSHD) gain muscle, lose fat, and improve physical abilities like walking and strength. About 48 adults with FSHD and healthy volunteers will participate. The goal is to see if this combination approach can ease symptoms and improve daily function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

facioscapulohumeral muscular dystrophy Motor Activity muscular dystrophy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

FSH muscular dystrophy Muscular dystrophy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

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Contacts and locations

Locations

  • Criams Sport Medicine Centre

    RECRUITING

    Voghera, Pavia, 27058, Italy

    Contact Email: •••••@•••••

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