Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT06721299

Clenbuterol to Target DUX4 in FSHD

Led by Jeffrey Statland · Updated on 2026-02-25

30

Participants Needed

3

Research Sites

157 weeks

Total Duration

On this page

Sponsors

J

Jeffrey Statland

Lead Sponsor

U

University of Washington

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to determine if Clenbuterol is a therapeutic option for FSHD by determining the safety and tolerability of the medication at three different dose levels.

CONDITIONS

Official Title

Clenbuterol to Target DUX4 in FSHD

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Genetically confirmed diagnosis of FSHD type 1 or 2, or clinical diagnosis of FSHD type 1 with a first degree relative with confirmed mutation
  • Between 18 and 75 years of age
  • Clinical severity score between 0 and 10
  • Able to walk 30 feet without support of another person
  • Showing anti-gravity strength on at least one tibialis anterior muscle or having an MRI eligible muscle in the leg for needle biopsy
  • Willing and able to provide informed consent
  • Agree to follow the contraceptive requirement for the duration of the study
Not Eligible

You will not qualify if you...

  • Pregnant or planning to become pregnant during the conduct of the study
  • Have a poorly controlled medical condition
  • Involved in a study of an experimental agent within 3 months of enrollment
  • Taking beta-blockers, anabolic agents, or potassium wasting diuretics
  • Taking or planning to take a GLP-1 Agonist during the trial
  • Have any condition or contraindication which would interfere with testing or preclude use of beta-agonist
  • Taking blood thinners or medications that contraindicate needle muscle biopsy
  • Have contraindication to lactose such as galactosmia, lactase deficiency, or glucose-galactose malabsorption
  • Taking any medications or therapies contraindicated with Clenbuterol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Actively Recruiting

2

University of Rochester Medical Center

Rochester, New York, United States, 14642

Actively Recruiting

3

University of Washington

Seattle, Washington, United States, 98104

Actively Recruiting

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Research Team

R

Rebecca Clay

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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