Who is eligible for clinical trial NCT06721299?

Participants must meet protocol criteria for Muscular Dystrophy, Facioscapulohumeral. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06721299 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-02-24

Clenbuterol to Target DUX4 in FSHD (NCT06721299)

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Jeffrey Statland

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (10 items).

Location: University of Kansas Medical Center — Kansas City, Kansas

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Genetically confirmed diagnosis of FSHD type 1 or 2, or have a clinical diagnosis of FSHD type 1 with a first degree relative with confirmed mutation
between 18 and 75 years of age
with a clinical severity score between 0 and 10
Able to walk 30ft without support of another person
Showing anti-gravity strength on at least one of the tibialis anterior muscles 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 duration of the study

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Pregnant or planning to become pregnant during the conduct of the study
have a poorly controlled medical condition
Were involved in a study of an experimental agent within 3 months of enrollment
Are taking beta-blockers or anabolic agent or potassium wasting diuretics
Are taking or are planning to take a GLP-1 Agonist during trial
have any condition or contraindication which would interfere with testing or preclude use of beta-agonist
Are taking blood thinners or medications which make a needle muscle biopsy contra-indicated
Has contraindication to lactose such as galactosmia, lactase deficiency and glucose-galactose malabsorption. For those who are lactose intolerant, the PI will determine acceptability based on tolerance reaction to lactose
Are taking any medications or therapies with a contraindication to Clenbuterol

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (3 Sites)

University of Kansas Medical Center — Kansas City, Kansas
University of Rochester Medical Center — Rochester, New York
University of Washington — Seattle, Washington

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗