Recruiting

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

Sponsor:

Ad scientiam

Code:

NCT05564936

Conditions

Myasthenia Gravis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

ME&MG mobile application

Study Details

Brief 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.

Conditions

Myasthenia Gravis

Study ID

NCT05564936

Start date

Jan 24, 2024

Status verified date

Apr, 2025

Completion date

Sep 24, 2026

Anticipated

Primary completion date

Sep 24, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

144 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: MG patients

MG patients will perform 3 in-clinic visits and use the ME\&MG app at-home during 12 months

other: Healthy volunteers

Healthy volunteers will perform one in-clinic visit and will use the app at-home once

Interventions

ME&MG mobile application

Primary outcome measure

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 [ Time Frame: baseline ]

Central Contacts and Locations

Central contacts

Pr Laforet

+33147107752 pascal.laforet@aphp.fr

Locations

University of Colorado Denver

Recruiting

Aurora, Colorado, United States, 80204

Contacts

Thomas Ragole, Dr

303-724-2188 thomas.ragole@cuanschutz.edu

Principal Investigator:

Dr Ragole

University of Florida Health

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

Michael T Pulley

(904) 383-1022 michael.pulley@jax.ufl.edu

Indiana University Health

Recruiting

Indianapolis, Indiana, United States, 46123

Contacts

Sara M Takacs

3179485450 stakacs@iuhealth.org

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Ima M Ebong

8592571000 Ima.Ebong@uky.edu

Neurological Associates of Long Island, P.C.

Recruiting

Lake Success, New York, United States, 11042

Contacts

Denis Ostrovskiy, MD

(516) 466-4700 dostrovskiy@neuroli.com

Duke University

Recruiting

Durham, North Carolina, United States, 27708

Contacts

Shruti Raja, Dr

919-684-5422 shruti.raja@duke.edu

Principal Investigator:

Dr Raja

OHSU

Recruiting

Portland, Oregon, United States, 97239

Contacts

Nizar Chahin, Dr

503-494-7772 chahin@ohsu.edu

Principal Investigator:

Dr Chahin

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19144

Contacts

Erika Wong, Dr

215 955-4672 Ericka.Wong@jefferson.edu

Principal Investigator:

Dr Wong

Vanderbilt Health

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Lindsay Malatesta, Dr

615 936-0600 lindsay.malatesta@vumc.org

Principal Investigator:

Dr Malatesta

More Information

Sponsor

Ad scientiam

Last update posted

Apr 11, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Ad scientiam on 2025-04-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.