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New tools aim to speed up FSHD drug trials

NCT ID NCT03458832

Knowledge-focused Sponsor: University of Kansas Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 2 times

Summary

This study involves 324 adults with facioscapulohumeral muscular dystrophy (FSHD) across 14 international sites. Researchers are testing two new measurement tools—a functional test called FSHD-COM and a muscle-impedance device—to better track disease progression. The goal is to improve how future drug trials are designed, making them faster and more effective.

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.

Participants

324 people

The number who actually took part.

Started

Mar 2018

Expected to finish

Dec 2027

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.

Who is studied

Participants with FSHD that are seen in the researchers clinic.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Patients with genetically confirmed FSHD1 or clinical diagnosis of FSHD with characteristic findings on exam and an affected parent or offspring * Patients with symptomatic limb weakness * Patients must be able to walk 30 feet without the support of another person or assistance (canes, walking sticks, and braces allowed; no walker). * If taking over the counter supplements, willing to remain consistent with supplement regimen throughout the course of the study Exclusion Criteria: * Patients with cardiac or respiratory dysfunction (deemed clinically unstable, or would interfere with safe testing, in the opinion of the Investigator) * Patients with orthopedic conditions that preclude safe testing of muscle function * Patients that regularly use available muscle anabolic/catabolic agents such as corticosteroids, oral testosterone or derivatives, or oral beta agonists * Patients that have used an experimental drug in an FSHD clinical trial within the past 30 days * Patients that are pregnant

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Conditions

The condition(s) this trial relates to.

facioscapulohumeral muscular dystrophy muscular dystrophy

As listed by the trial registrant

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

Facioscapulohumeral muscular dystrophy

Contacts and locations

Locations

  • Centro Clinico NeMO

    Milan, 20162, Italy

  • Chu De Nice

    Nice, 06001, France

  • Institut de Myologie

    Paris, 75013, France

  • Kennedy Krieger Institute

    Baltimore, Maryland, 21205, United States

  • Ludwig-Maximilians-Universität München

    München, 80336, Germany

  • Radboud Unviersity

    Nijmegen, 6525 XZ, Netherlands

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • University of California Los Angeles

    Los Angeles, California, 90095, United States

  • University of College London - Queens Square

    London, WC1N 3BG, United Kingdom

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.