Digital self-assessment tool for monitoring Myasthenia Gravis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The ME&MG digital solution is a mobile application designed for patients with Myasthenia Gravis (MG) to perform unsupervised self-assessments of their symptoms. It includes digital tests for various physical functions and validated questionnaires to monitor daily activities, pain, fatigue, and mental health. The study aims to validate the accuracy and reliability of this tool compared to traditional in-clinic assessments, while also evaluating its safety and user satisfaction. By leveraging technology, the study seeks to improve the management of MG and enhance patient engagement in their own care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• University of Colorado Denver
  Aurora, Colorado, United States Recruiting
• University of Florida Health
  Jacksonville, Florida, United States Recruiting
• Indiana University Health
  Indianapolis, Indiana, United States Recruiting
• University of Kentucky
  Lexington, Kentucky, United States Recruiting
• Neurological Associates of Long Island, P.C.
  Lake Success, New York, United States Recruiting
• Duke University
  Durham, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Pr Laforet
• Email: pascal.laforet@aphp.fr
• Phone: +33147107752

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Early ravulizumab for adults with myasthenic crisis in the ICU

  This project will test whether giving ravulizumab early to adults with AChR-positive generalized myasthenia gravis who are in the ICU for a myasthenic crisis helps speed recovery.

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• KITE-363 treatment for relapsed or refractory autoimmune neurologic diseases

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• ADAPT Forward master protocol testing multiple regimens for generalized myasthenia gravis

  This platform tests several drug regimens, including efgartigimod IV and empasiprubart IV, in adults with generalized myasthenia gravis to find safer and more effective treatment combinations.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.