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

Launched by AD SCIENTIAM · Sep 29, 2022

Keywords

ClinConnect Summary

The ME&MG clinical trial is studying a new digital tool called ME&MG, which helps people with Myasthenia Gravis (MG) assess their symptoms at home using their smartphones. This tool allows patients to perform various tests related to their condition, such as checking for muscle weakness, breathing, and speech issues, as well as answering questionnaires about pain, fatigue, sleep, and mood. The goal is to see if this self-assessment method is as accurate and reliable as traditional in-clinic tests done by healthcare providers.

To be eligible for this trial, participants need to be between 18 and 60 years old, diagnosed with generalized Myasthenia Gravis, and have a specific type of antibody related to the condition. They must also own a smartphone and be able to use it. Those who have recently undergone certain treatments or have other health issues that could affect their participation may not qualify. Participants can expect to use the ME&MG tool at home and report their findings, helping researchers understand how well this digital solution works for monitoring MG symptoms. It's an opportunity to contribute to improving care for others with this condition.

Gender

ALL

Eligibility criteria

• 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.