Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-24 @ 12:15 PM
NCT ID:
NCT05453461
Eligibility Criteria:
Inclusion Criteria:
* Genetically confirmed FSHD1 or clinical diagnosis of FSHD with characteristic findings on exam and an affected parent or offspring
* Age 18-75 years
* Symptomatic limb weakness
* FSHD patients who use the wheelchair daily and are able to stand or to walk at most 30 meters with assistance, and wheelchair-bound patients who are unable to walk.
* Clinical severity score (CSS) ≥ 8
* Patient affiliated to the social security system
* Patient giving written consent after written and oral information.
* If taking over the counter supplements, willing to remain consistent with supplement regimen throughout the course of the study
Exclusion Criteria:
* Patients with comorbidity not related to the disease that can modify the natural evolution of the disease or would interfere with safe testing in the opinion of the Investigator
* Regular use of available muscle anabolic/catabolic agents such as corticosteroids, oral testosterone or derivatives, or oral beta agonists
* Use of an experimental drug in an FSHD clinical trial within the past 30 days
* Pregnancy
* Vulnerable person (person deprived of their administrative and legal liberty, hospitalized person for other purposes than research)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05453461
Study Brief:
Protocol Section:
NCT05453461