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New study tracks Long-Term safety of muscle stiffness drug namuscla

NCT ID NCT04616807

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study followed 53 adults with non-dystrophic myotonic disorders who were taking Namuscla (mexiletine) to manage muscle stiffness. Researchers monitored side effects and how often patients needed to reduce their dose or stop treatment over up to 36 months. The goal was to see if the drug remains safe and effective with long-term use.

What this could mean

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

Active substance
Mexiletine (Namuscla)
What this could lead to
If successful, this study could confirm that Namuscla is safe and effective for long-term use in managing muscle stiffness.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It only includes 53 participants, and side effects or lack of effectiveness could still occur.

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

Study facts

What this study's own registry entry says, in plain language.

Participants

53 people

The number who actually took part.

Started

Dec 2020

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study will target the enrolment of 50 patients who are treated with Namuscla.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adult, male or female patients with non-dystrophic myotonic disorders planned to be started on Namuscla according to the approved SmPC 2. Patients already receiving Namuscla/mexiletine for the treatment of NDM; (for patients on mexiletine other than Namuscla, only those who switch to Namuscla will be enrolled). 3. Patients who understand and are willing to provide informed consent. Exclusion Criteria: 1. Patients who are enrolled or participating in any other clinical trial for an investigational product. - 2. Hypersensitivity to mexiletine, or to any of the excipients of Namuscla, or hypersensitivity to any local anaesthetic 3. Ventricular tachyarrhythmia 4. Atrial tachyarrhythmia, fibrillation or flutter 5. Complete heart block (ie, third-degree atrioventricular block) or any heart block susceptible to evolve to complete heart block (first-degree atrioventricular block with markedly prolonged PR interval (≥ 240 ms) and/or wide QRS complex (≥ 120 ms), second-degree atrioventricular block, bundle branch block, bifascicular and trifascicular block), 6. Myocardial infarction (acute or past), or abnormal Q-waves 7. Symptomatic coronary artery disease 8. Heart failure with reduced ejection fraction \<50% 9. Sinus node dysfunction (including sinus rate \< 50 bpm) 10. Patients receiving drugs that can induce torsades de pointes 11. Patients receiving medicinal products with narrow therapeutic index (ie, theophylline, tizanidine, digoxin, lithium, phenytoin or warfarin) 12. Patients who are pregnant or lactating.

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Conditions

The condition(s) this trial relates to.

myotonic dystrophy nondystrophic myotonia

As listed by the trial registrant

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

Myotonic dystrophy

Contacts and locations

Locations

  • CHRU Lille

    Lille, 59000, France

  • Hôpital Universitaire de La Pitié Salpêtrière

    Paris, Cedex, 13 75013, France

  • Institute of Neurology

    London, England, WC1N 3BG, United Kingdom

  • Nottingham University Hospitals NHS Trust

    Nottingham, England, NG7 2UH, United Kingdom

  • St. Josef-Hospital Klinikum der Ruhr Universitaet Bochum

    Bochum, North Rhine-Westphalia, 44791, Germany

  • Universitätsklinikum Ulm, Klinik für Neurologie

    Ulm, 89081, Germany

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