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ME&MG Digital Solution for Myasthenia Gravis Assessment

This study is testing a new smartphone app called ME&MG for people with myasthenia gravis (MG), a condition that causes muscle weakness. The app helps you assess your symptoms at home without a doctor present. Researchers want to see if the results from the ME&MG app are similar to the results from standard tests done in a clinic. To join, you need to be over 18, diagnosed with generalized MG (MGFA Class II, III, or IV), and have specific antibodies (anti-AChR autoantibody) in your blood. The main goal is to show that the at-home app results match the in-clinic test results.

Study design
This interventional study plans to enroll 144 participants. It aims to compare unsupervised at-home assessments using the ME&MG app with standard supervised in-clinic tests.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at baseline, but the duration of follow-up after this is not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05564936

The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis

Recruiting
NAAges 18+Interventional
Ad scientiam
~144 participants
Updated 2025-04-11 on ClinicalTrials.gov
What's tested:ME&MG mobile application

At a glance

Recruiting sites
15 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To demonstrate that ME&MG tests results performed at-home, under unsupervised condition, are correlated to standard tests results performed in-clinic, under supervised conditions
Measured over baseline

Conditions

Myasthenia Gravis

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Where it's being run

19 sites across 10 states
France8
Indiana2
Tennessee2
Colorado1
Florida1
Kentucky1
New York1
North Carolina1

Who to contact

Pr Laforet
[email protected]
+33147107752
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Aged over 18 Years
Diagnosed with gMG at screening with generalized muscle weakness meeting the clinical criteria for diagnosis of MG, as defined by the MGFA Clinical Classification Class II, III, or IV, and likely not in need of a respirator for the duration of the study, as judged by the investigator
With positive serologic testing for anti-AChR autoantibody at screening
Have read the information sheet and signed the informed consent form
Own a personal smartphone which software version is above 13 for IOS and 8 for Android included
Able to use a smartphone
Able to read language in which the mobile application is available (French, English, Spanish) and able to understand pictograms

Exclusion

Subjects having undergone thymectomy Plasma Exchange Therapy or Intravenous Immunoglobulin Therapy within four weeks of screening
Subjects having initiated FcRn inhibitor therapy within the four weeks preceding screening
Known medical or psychological condition(s) or risk factor(s) that, as judged by the investigator, might interfere with the subject's full participation in the study, pose any additional risk for the subject, or confound the assessment of the subject or outcome of the study.
Pregnant and nursing women
Person under guardianship or curatorship
Current drugs or/and alcohol abuse that could influence performance on the tests, as judged by the investigator
Participant included in another ME\&MG clinical study
Participant has participated in another clinical study within the previous 30 days of screening or is currently participating in another study that, in the opinion of the Investigator, might interfere with the subject's full participation in the study or confound the assessment of the subject or outcome of the study.

What this trial measures

  • To demonstrate that ME&MG tests results performed at-home, under unsupervised condition, are correlated to standard tests results performed in-clinic, under supervised conditionsbaseline

    Pearson correlation coefficient will be used to assess the relationship between digital tests versus standard tests