Status:
COMPLETED
Pro-inflammatory Cytokines in Facioscapulohumeral Muscular Dystrophy (CYTOKINE-FSH)
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Muscular Dystrophies
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The facial-glenohumeral muscular dystrophy type 1 (DMFSH1) is characterized by a selective and asymmetrical involvement of the facial muscles, the shoulder girdle and the anterolateral lodge legs. Gen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04694456
Start Date
January 30 2018
End Date
May 18 2021
Last Update
November 15 2023
Active Locations (1)
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1
CHU de NICE
Nice, France