Status:

RECRUITING

Ten Year Follow-up in FSHD: the FOCUS 3 Study

Lead Sponsor:

Radboud University Medical Center

Conditions:

FSHD - Facioscapulohumeral Muscular Dystrophy

Eligibility:

All Genders

6+ years

Brief Summary

This study aims to assess longitudinal data in 170 adult and 30 pediatric genetically and clinically well-defined facioscapulohumeral dystrophy (FSHD) patients. FSHD is a chronic progressive disorder ...

Eligibility Criteria

Inclusion

  • All 162 genetically confirmed FSHD patients that participated in the FSHD-FOCUS 2 and 18 genetically conformed pediatric FSHD patient that participated in the FSHD-iFocus study and are informed about the genetic confirmation of FSHD. The 65 newly included patients need to provide genetical confirmation of the disease.

Exclusion

  • No incapacitated persons will be included in this study. Persons with contra-indications for MRI-scan are excluded for that one procedure, but can be included in the study. Contraindications for MRI-scan include metallic implants (vascular clips, foreign bodies like metallic splinters in the eye, coronary and peripheral artery stents, prosthetic heart valves, pacemakers and ICD's, cochlear implants, breast tissue expanders and some other electronic implants or devices), renal insufficiency, previous allergic reaction to contrast fluids and known claustrophobia.
  • Participant in medication trial

Key Trial Info

Start Date :

September 1 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 30 2025

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT06911190

Start Date

September 1 2024

End Date

December 30 2025

Last Update

April 4 2025

Active Locations (1)

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Radboudumc

Nijmegen, Netherlands