The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis
Ad scientiam · NCT05564936
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 144
- US sites recruiting
- 9
- Study start
- January 24, 2024
- Record last updated
- April 11, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: ME&MG mobile application
Conditions: Myasthenia Gravis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
University of Colorado Denver
Aurora, CO 80204
Site contact: Thomas Ragole, Dr · 303-724-2188 · thomas.ragole@cuanschutz.edu
University of Florida Health
Jacksonville, FL 32209
Site contact: Michael T Pulley · (904) 383-1022 · michael.pulley@jax.ufl.edu
Indiana University Health
Indianapolis, IN 46123
Site contact: Sara M Takacs · 3179485450 · stakacs@iuhealth.org
University of Kentucky
Lexington, KY 40536
Site contact: Ima M Ebong · 8592571000 · Ima.Ebong@uky.edu
Neurological Associates of Long Island, P.C.
Lake Success, NY 11042
Site contact: Denis Ostrovskiy, MD · (516) 466-4700 · dostrovskiy@neuroli.com
Duke University
Durham, NC 27708
Site contact: Shruti Raja, Dr · 919-684-5422 · shruti.raja@duke.edu
OHSU
Portland, OR 97239
Site contact: Nizar Chahin, Dr · 503-494-7772 · chahin@ohsu.edu
Thomas Jefferson University
Philadelphia, PA 19144
Site contact: Erika Wong, Dr · 215 955-4672 · Ericka.Wong@jefferson.edu
Vanderbilt Health
Nashville, TN 37232
Site contact: Lindsay Malatesta, Dr · 615 936-0600 · lindsay.malatesta@vumc.org
Study contacts (from the official record)
- Pr Laforet · +33147107752 · pascal.laforet@aphp.fr
Similar studies in Colorado
All healthy volunteers studies in Colorado →- RecruitingHealthy volunteersPhase 1/Phase 2
A Study of BLB-201 RSV Vaccine in Infants and Children
Blue Lake Biotechnology Inc.
- Location
- Aurora, CO + 13 other US sites
- Eligibility basics
- Ages 6 mo–5
- RecruitingHealthy volunteersPhase 1
Study to Evaluate the Safety, Pharmacokinetic, and Pharmacodynamic Effects of MY006 in Healthy Volunteers and Patients With Peanut Allergy
Mabylon AG
- Location
- Aurora, CO + 7 other US sites
- Eligibility basics
- Ages 12–55
- RecruitingHealthy volunteersPhase 1
A Research Study Looking at How Different Doses of Study Medicine (Inno8) Work in the Body of People With Haemophilia A
Novo Nordisk A/S
- Location
- Aurora, CO + 4 other US sites
- Eligibility basics
- Ages 18–64 · Men only
- RecruitingHealthy volunteersPhase 1/Phase 2
A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)
Novartis Pharmaceuticals
- Location
- Aurora, CO + 18 other US sites
- Eligibility basics
- Ages 18–100