New hope for muscle stiffness: Once-Daily pill tested in myotonic dystrophy

NCT ID NCT06523400

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This Phase 3 trial tests whether a once-daily dose of mexiletine PR can safely reduce muscle stiffness (myotonia) in people with myotonic dystrophy types 1 and 2. About 176 participants will receive either the drug or a placebo for 26 weeks. The main measure is how quickly hand muscles relax after a strong squeeze.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
mexiletine PR (prolonged-release granules for oral suspension)
What this could lead to
If successful, this could provide a once-daily treatment option to reduce muscle stiffness and improve daily function for people with myotonic dystrophy.
What could go wrong
This is a Phase 3 trial, but it's still testing a drug that may not work better than placebo. Side effects are possible, and the benefit may be modest or not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Aarhus University Hospital

    RECRUITING

    Aarhus, Denmark

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    RECRUITING

    Rome, Italy

  • Laboratory for Muscle Diseases and Neuropathies

    RECRUITING

    Leuven, Belgium

  • Ludug-Maximilians University

    RECRUITING

    München, Germany

  • Saint George's University Hospitals NHS Foundation Trust

    RECRUITING

    London, United Kingdom

  • University College Hospital

    RECRUITING

    London, United Kingdom

  • University Hospital of Madrid

    RECRUITING

    Madrid, Spain

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