Towards the assessment of metabolic biomarkers and creatine uptake and turnover in skeletal muscles of patients with Facioscapulohumeral muscular dystrophy using MR spectroscopy - Assessment of biomarkers in FSHD

• Conditions: Healthy volunteers. Later the protocol will be applied to Facioscapular humeral dystrophy and/or other muscular dystrophies in general.; MedDRA version: 8.1Level: LLTClassification code 10011328Term: Creatine

• Registration Number: EUCTR2006-006776-37-NL
• Lead Sponsor: Radboud University Nijmegen Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

FSHD patients: clinically affected patients with a genetically confirmed diagnosis, moderate severity of the disease, informed consent.
Heatlhy volunteers: informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

All subjects: kidney or liverproblems (present or past), diabetes, wheelchair bound. MR contra-indication: pacemaker, cerebral clips, metal splinters, neuro stimulator, cardiac arythmias, epilepsy, severe claustrofobia, pregnancy.
Healthy volunteers: skeletal muscle problems or disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified