Phase 3 Muscular Dystrophy Trial, Recruiting NCT05532813 Sponsor: Assistance Publique - Hôpitaux de Paris Condition: Muscular Dystrophy
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Phase 3 Muscular Dystrophy Trial, Recruiting

NCT05532813
Recruiting Phase 3

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 diagnosed with Myotonic Dystrophy Type 1 (DM1), confirmed by a genetic test
  • You are between 18 and 70 years old
  • You are able to walk, even if you need a walking stick for support
  • Your level of muscle involvement falls within a specific range on a disease severity scale called MIRS (score 3 or 4) — (confirm with trial site)
  • If you are a woman who could become pregnant, you are using effective contraception throughout the study
  • You are able to understand and agree to take part in the study yourself
  • You have read and signed the study's consent form
  • You are covered by a social security or health insurance system

Who may not be able to join:

  • Women who are pregnant or currently breastfeeding
  • Men who are planning to have a child during the study period
  • Anyone who has an allergy or sensitivity to Metformin or any of its ingredients
  • People who need a tracheotomy (a breathing tube in the throat) or who rely on a breathing machine for more than 12 hours a day, or whose breathing is not adequately supported by a machine
  • People whose kidneys are not filtering blood well enough (confirmed by a blood test) — (confirm with trial site)
  • People with certain heart conditions, including poor heart pumping ability, abnormal electrical activity in the heart without a pacemaker or defibrillator, certain types of heart rhythm problems, or a dangerous fast heart rhythm
  • People who have a sudden or serious illness that reduces oxygen supply to their body's tissues

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 26 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Pascal LAFORÊT, MD, PhD, Neurology Department, Raymond Poincaré Hospital, APHP

Phone: +33 (0)1 47 10 77 36

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
Phase 3
Registry
ClinicalTrials.gov
Start date
29 November 2024
Est. completion
1 November 2026

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Change of muscle function

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: 26 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