Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT03458832

Clinical Trial Readiness to Solve Barriers to Drug Development in FSHD

Sponsor: University of Kansas Medical Center

View on ClinicalTrials.gov

Summary

The primary cause of facioscapulohumeral muscular dystrophy (FSHD), a common adult-onset dystrophy, was recently discovered identifying targets for therapy. As multiple drug companies pursue treatments for FSHD, there is an urgent need to define the clinical trial strategies which will hasten drug development, including creating disease-relevant outcome measures and optimizing inclusion criteria. This proposal will develop two new outcome measures (FSHD-COM and EIM) and optimize eligibility criteria by testing 320 patients across 14 international sites over a period of 24 months.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

320

Start Date

2018-03-05

Completion Date

2027-12

Last Updated

2025-04-23

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

FSHD-specific functional rating scale

The FSHD-COM is composed of disease-relevant functional tasks such as leg function; shoulder and arm function; trunk function, hand function, and balance.

DEVICE

Electrical Impedance Myography

EIM is a non-invasive, painless, and fast technique for obtaining information on how a patient's muscle structure is changing. EIM uses a small electrical current to measure the health of the underlying muscle. The patient will be asked to lie down and a trained clinical evaluator will perform testing on 16 total muscles (8 on each side) on your arms and legs.

Locations (14)

University of California Los Angeles

Los Angeles, California, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Kennedy Krieger Institute

Baltimore, Maryland, United States

University of Rochester Medical Center

Rochester, New York, United States

The Ohio State University

Columbus, Ohio, United States

University of Utah

Salt Lake City, Utah, United States

Virginia Commonwealth University

Richmond, Virginia, United States

University of Washington

Seattle, Washington, United States

Chu De Nice

Nice, France

Institut de Myologie

Paris, France

Ludwig-Maximilians-Universität München

München, Germany

Centro Clinico NeMO

Milan, Italy

Radboud Unviersity

Nijmegen, Netherlands

University of College London - Queens Square

London, United Kingdom