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:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT06079567
Eligibility Criteria:
Inclusion criteria:
* Genetically confirmed FSHD2: pathogenic mutation in SMCHD1 gene and at least one D4Z4 4qA allele;
* Age 18-75 years
* Symptomatic limb weakness
* Clinical severity score of 2 to 5 (RICCI score; range 0-5), inclusive, at screening:
* Group ambulant patient with a RICCI score of 2 to 4
* Group non-ambulant patient with a RICCI score of 5
* Patient giving written consent after written and oral information
* Patient affiliated to a social security system
* If taking over the counter supplements, willing to remain consistent with supplement regimen throughout the course of the study
Non inclusion 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
* Contraindication to muscle MRI as per clinic standard practice
* Patients who has been to a tropical or subtropical country during the last 3 months
* Patients who has practiced physical exercise within 10 hours before blood test
* Patients declaring not to be fasting for at least 10 hours
* Patients following a particular diet for medical reasons and after prescription by a doctor or dietitian
* Patients who regularly consumes large quantities of alcohol
* Patients having consumed an illicit recreational drug during the last 3 months
* Patients having been vaccinated during the last 3 months
* Patients having received a blood transfusion or immunoglobulins during the last 3 months
* Patients declaring to be seropositive for HIV, HBV or HCV
* Patients having had an infectious episode during the 3 weeks preceding the visit
* Use of an experimental drug in an FSHD clinical trial within the past 30 days
* Participation in others clinical trials
* Pregnant women, breastfeeding women, women of childbearing age without contraception Pregnancy
* Patient with legal protection measures (future protection mandate, family empowerment, guardianship, curators) under Article L. 1122-2 of the French Public Health Code
* Patient refusing to participate in the study or expressing opposition to participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06079567
Study Brief:
Protocol Section:
NCT06079567