Myotonia Treatment: Mexiletine PR vs. Mexiletine IR

We are comparing two forms of mexiletine to see which one is safer and more effective for adults with non-dystrophic myotonias. This study aims to improve treatment options for conditions like myotonia congenita and paramyotonia congenita.

6-12 monthsConfirmation phase (III)No PlaceboCost ReimbursementStandard MedicinesOralInternal MedicineNeurology

What diseases are being studied?

Health conditions and diseases that the clinical trial is designed to study and treat.

Who can participate in the clinical trial?

These questions help us understand your situation so we can let the trial team know whether you might be a potential match. This is not a medical evaluation and is not part of the official screening, the study doctor will make the final decision..

What medicines are being studied?

Medicines that are officially approved for use in the European Union and considered safe by EMA. These medicines are already on the market and may be tested for new conditions or populations.

Mexiletine Hydrochloride Clinigen Healthcare
A medicine used to treat serious abnormal heart rhythms originating in the heart's lower chambers.
Namuscla

What active substances are being studied?

Active substances that are officially approved for use in the European Union and considered safe by EMA. These substances are already on the market and may be tested for new conditions or populations.

Mexiletine
Mexiletine is a substance used to treat abnormal and potentially dangerous heart rhythms by calming the heart’s electrical activity.
Mexiletine Hydrochloride
Mexiletine hydrochloride is a substance that helps control abnormal heart rhythms, especially ventricular arrhythmias.

What similar medicines might you know?

Don't worry if you don't know the medicines tested in the trial. There is a chance you have heard about the similar medicines. Check the list below to see if you are familiar with any of them.

Dopital
Dopital
Ritalmex

Where is the clinical trial being conducted?

Locations and medical facilities where this clinical trial is currently recruiting or conducting research. Select the locations where you would like to participate.

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UZ Leuven
Department of Neurology, Neuromuscular Reference Centre (NMRC)
Heverlee, Belgium
Hopital Erasme
Service de Neurologie, Erasme-HUDERF Neuromuscular Reference Center (CRNM)
Negenmanneke, Belgium
Assistance Publique Hopitaux De Paris
Service of Neuromyology
Salpêtrière, France
Sponsor: Lupin Atlantis Holdings S.A.
Last updated: Nov 27, 2025

Disclaimer: Parts of this content have been automatically extracted from the EU Clinical Trials registry. While we strive for accuracy, please always contact the trial site or sponsor directly for correct and official information before making any decisions about participation. View on EU Clinical Trials.