New registry tracks safety of mexiletine in kids with myotonia

NCT ID NCT07154654

Recruiting now Symptom relief Sponsor: Lupin Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study follows up to 10 children from birth to under 6 years old who have genetic muscle disorders causing stiffness (myotonia) and are taking mexiletine. Researchers will collect data on side effects and how the medicine is used in routine care over the long term. The goal is to better understand the safety of mexiletine in this young age group.

What this could mean

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

Active substance: mexiletine
What this could lead to: If successful, this study could provide valuable safety data to guide mexiletine use in young children with myotonic disorders, potentially improving symptom management.
What could go wrong: This is a small, observational registry (10 participants) with no control group, so results may not be widely applicable. It focuses on safety, not effectiveness, and mexiletine carries risks like heart rhythm issues.

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Conditions

The condition(s) this trial relates to.

myotonic dystrophy type 1 myotonic dystrophy type 2 myotonic syndrome nondystrophic myotonia

As listed by the trial registrant

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

MYOTONIC DISORDERS

Contacts and locations

Locations

Centre Hospitalier Universitaire de Clermont-Ferrand
RECRUITING

Clermont-Ferrand, France

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