Status:
ACTIVE_NOT_RECRUITING
Clinical Trial Readiness Network FSHD France: Prospective 24 Months MRI Study
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Muscular Dystrophy
Facioscapulohumeral
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The overall aim of this study is to hasten drug development for facioscapulohumeral muscular dystrophy (FSHD). Recent breakthroughs in FSHD research have identified the primary disease mechanism as th...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Genetically confirmed FSHD1 or clinical diagnosis of FSHD with characteristic findings on exam and an affected parent or offspring 63
- Age 18-75 years
- Symptomatic limb weakness
- Patient able to walk alone or with a walking aid.
- Manual Muscle Testing (MMT) score ≥ 4 for one of the lower limb muscles
- 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
- Cardiac or respiratory dysfunction (deemed clinically unstable, or would interfere with safe testing in the opinion of the Investigator)
- Orthopedic conditions that preclude safe testing of muscle function
- 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.
- Contraindication for muscle MRI
- Any major comorbidity
Exclusion
Key Trial Info
Start Date :
September 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04038138
Start Date
September 16 2019
End Date
September 3 2026
Last Update
December 3 2025
Active Locations (3)
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1
CHRU de Lille
Lille, Hauts-de-France, France, 59000
2
CHU de Nice
Nice, Provence-Alpes-Côte d'Azur Region, France, 06000
3
Myology institute Association
Paris, Île-de-France Region, France, 75013