NCT06721299 Clenbuterol to Target DUX4 in FSHD
| NCT ID | NCT06721299 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Jeffrey Statland |
| Condition | Muscular Dystrophy, Facioscapulohumeral |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-06-25 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-06-25 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06721299 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Muscular Dystrophy, Facioscapulohumeral. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06721299 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06721299 currently recruiting?
Yes, NCT06721299 is actively recruiting participants. Contact the research team at rclay@kumc.edu for enrollment information.
Where is the NCT06721299 trial being conducted?
This trial is being conducted at Kansas City, United States, Rochester, United States, Seattle, United States.
Who is sponsoring the NCT06721299 clinical trial?
NCT06721299 is sponsored by Jeffrey Statland. The trial plans to enroll 30 participants.