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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT04694456
Eligibility Criteria:
Inclusion Criteria:
* male or female age 18 to 75
* suffering from genetically confirmed FSHD1 (\<11 D4Z4 repeat units on permissive chromosome 4 allele)
* ambulant or walking with assistance
* Manual Muscle Testing ≥4 for 1 of lower limb muscles
Exclusion Criteria:
* pregnancy or breast feeding
* stay in tropical/subtropical country within 3 months
* physical exercice within 10 hours
* specific diet (e.g. hypocaloric or cholesterol lowering diet)
* regular alcohol consumption; drug consumption within 3 months
* immunosuppressive or immonumodulating drug within 2 weeks or for more than 3 months withing last 6 months
* vaccination, blood transfusion of immunoglobulin treatment within 3 months
* infection within 3 weeks; HIV, HBV, HCV seropositivity
* chronic inflammatory and/or autoimmune or allergic disease from the gut (Crohn disease, ulcerative colitis), skin (psoriasis, atopic dermatitis), joints (rhumatoid arthritis), nervous system (multiple sclerosis), diabetes type I and II
* neurodegenerative disorders (Alzheimer's or Parkinson's diseases)
* diagnosed cancer not under remission for at least 5 years
* participation in the last 3 months in a research clinical trial with exposure to a pharmaceutical product or a medical device
* muscular MRI contraindication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04694456
Study Brief:
Protocol Section:
NCT04694456