Muscular Dystrophy Trial, Recruiting NCT06079567 Sponsor: Centre Hospitalier Universitaire de Nice Condition: Muscular Dystrophy
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Muscular Dystrophy Trial, Recruiting

NCT06079567
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been confirmed through genetic testing to have FSHD2, meaning you have a specific change in the SMCHD1 gene and a related genetic feature called a D4Z4 4qA allele
  • You are between 18 and 75 years old
  • You have noticeable muscle weakness in your arms or legs
  • Your disease falls within a certain range of severity (called a RICCI score of 2 to 5) — either you can still walk (score 2–4) or you can no longer walk (score 5)
  • You are willing to give written consent to take part after receiving information about the study
  • You are covered by a social security/health insurance system
  • If you currently take any over-the-counter supplements, you are willing to keep taking them at the same level throughout the study

Who may not be able to join:

  • You have another health condition (unrelated to FSHD2) that could affect how your disease progresses or make testing unsafe, in the opinion of the study doctor
  • You regularly use certain muscle-affecting medications such as steroids, oral testosterone or similar drugs, or oral beta agonists
  • You have a reason why you cannot safely have a muscle MRI scan
  • You have travelled to a tropical or subtropical country in the last 3 months
  • You have exercised within 10 hours before your blood test appointment
  • You have not fasted (gone without food) for at least 10 hours before your blood test
  • You are following a special diet for medical reasons prescribed by a doctor or dietitian
  • You regularly drink large amounts of alcohol
  • You have used an illegal recreational drug in the last 3 months
  • You have received a vaccine in the last 3 months
  • You have received a blood transfusion or immunoglobulins (a type of antibody treatment) in the last 3 months
  • You have tested positive for HIV, Hepatitis B (HBV), or Hepatitis C (HCV)
  • You have had an infection in the 3 weeks before your study visit
  • You have taken an experimental drug in an FSHD clinical trial within the last 30 days
  • You are currently taking part in another clinical trial
  • You are pregnant, breastfeeding, or able to become pregnant and not using contraception
  • You are under a legal protection order or guardianship arrangement as defined under French law (confirm with trial site)
  • You do not wish to take part or have expressed that you do not want to participate

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 0492035757

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
3 October 2023
Est. completion
1 April 2026

Where this trial is recruiting

🇧🇪 Belgium 🇫🇷 France 🇮🇹 Italy 🇳🇱 Netherlands 🇪🇸 Spain

Primary endpoints

Minimal clinical importance of the Motor Function Measure-32 (MFM-32) from Baseline (V1) to 18 months (V3)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov