Clinical Trial

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

Recruiting
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Record status
This record was last updated April 11, 2025 (before its estimated September 24, 2025 completion). Its status may not reflect the trial's current state.
Summary
ME\&MG is a standalone software (digital solution) running on patients smartphones, connected to a web portal for physicians. It is intended to be used as an unsupervised digital self-assessment tool for the monitoring of disabilities in patients living with MG. ME\&MG contains digital active tests for the assessment of ptosis, breathing, dysarthria, upper- and lower-limb (arms and legs) weakness, treatment follow-up, and validated e-questionnaires related to daily activities, pain, fatigue, sleep, and depression disorders. The objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone with ME\&MG versus the standard in-clinic testing, as well as to evaluate the safety of the solution, its usability and satisfaction.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2022-09-29; most recent amendment 2025-04-08.
Status change: Not Yet Recruiting → Recruiting 2023-12-12
Trial Details
NCT Number NCT05564936
Lead Sponsor Ad scientiam
Conditions Myasthenia Gravis
Enrollment 144 participants
Start Date 2024-01-24
Primary Completion 2025-09-24 (estimated)
Study Completion 2026-09-24 (estimated)
Updated on ClinicalTrials.gov 2025-04-11