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Can watching the course of myotonic dystrophy unlock better care?

NCT ID NCT07732439

Knowledge-focused 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This study follows 100 adults with myotonic dystrophy (types 1 or 2) for two years to understand how muscle stiffness, daily function, and heart health change over time. Researchers will look back at up to 18 months of past medical records and then track participants with clinic visits at the start, 12 months, and 24 months. The goal is to map the natural course of the disease and identify which symptoms most affect quality of life.

What this could mean

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

What this could lead to
If successful, this study could help doctors better predict how myotonic dystrophy progresses and identify which symptoms matter most to patients.
What could go wrong
This is an observational study, not a treatment trial, so it will not test any new therapy. The small number of participants (100) may limit how broadly the findings apply.

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

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

All patients will be recruited from DM-Scope Registry

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Enrolled in DM-scope registry genetically diagnosed with DM1 or DM2. * Affiliation or beneficiary of a social security system or of such a regime. * Ability to comprehend and willingness to sign an informed consent (ICF). * Male or non-pregnant female ≥18 years of age at screening. * Body Mass Index (BMI) of 18.5 kg/m2 to 30 kg/m2, and weight ≥45 kg. * Medical history data covering up to 18 months prior to enrollment. * Clinical sign of myotonia * DM1 patients only - Muscular impairment rating scale (MIRS) score of 2, 3 or 4. * Be able to walk independently 10 meters (cane, walker, orthoses allowed). Exclusion Criteria: * No informed consent. * Pregnant or lactating women. * Subjects benefiting from laws aimed at protecting vulnerable adults: subjects being deprived of liberty by judicial or administrative decision, subjects under guardianship /curatorship. * Any medical condition or serious medical illness which in the opinion of the Investigator, precludes the participant's participation in the study or the participant is unlikely to comply with the protocol-defined procedures and therefore is unlikely to complete the study. * Medical conditions that could affect hand functioning including (but not limited to) rheumatoid arthritis, Dupuytren's contracture, hand deformity, severe arthritis or any other medical condition (other than DM1/DM2) that would significantly impact ambulation. * Patients with no documented record of myotonia assessment in the clinical records of the DM-scope database or myotonia absence at last visit prior to study enrolment. * Not able to perform study specific performance tests and evaluations e.g. hand grip dynamometry, 10mWT, etc. (in the opinion of the investigator). * Treatment with mexiletine within 18 months prior to baseline (Day 1).

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU LA TIMONE - Service des Maladies

    Marseille, 13005, France

  • CHU de Lille - Hôpital

    Lille, 59037, France

  • CHU de Toulouse - Hôpital

    Toulouse, 40031, France

  • Centre de référence des maladies neuromusculaires

    Nantes, 44093, France

  • Centre hospitalier Universitaire d'Angers

    Angers, 75651, France

  • Hôpital Pitié Salpêtrière

    Paris, 75013, France

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