Press Release Courtesy of EIN Presswire and Ad Scientiam.
The ME&MGopen study has already recruited 165 patients in the USA and 11 in Canada. This innovative program is supported by Alexion, AstraZeneca Rare Disease.
PARIS, FRANCE, September 21, 2023 /EINPresswire.com/ — Generalized Myasthenia Gravis (gMG) is a chronic autoimmune neuromuscular disease that causes fatigue and muscle group weakness. Symptoms can include eyelid drooping, double vision, difficulty speaking and swallowing, as well as weakness in the arms and legs. The course of gMG is complex, highly fluctuating, heterogeneous and critical to monitor.
The ME&MGopen clinical study (NCT05566964) utilizes the
ME&MGopenTM smartphone application, an investigational software developed by Ad Scientiam for research purposes. The application features digital tests to collect data on respiratory capacity, dysarthria, ptosis, as well as upper and lower limb muscle function. It also includes e-questionnaires related to activities of daily living, pain, insomnia, quality of life and depression.
“The successful launch of a completely decentralized study across the world will help us create a more inclusive approach of gMG and potentially improve patient care.” said Dr. James F. Howard Jr., Professor of Neurology at The University of North Carolina Chapel Hill School of Medicine, coordinating investigator for the USA.
“The launch of the ME&MGopen clinical study represents a major advancement in our mission to empower patients through real-time digital data sharing,” said Dr. Saad Zinaï, Chief Medical Officer at Ad Scientiam. “Now that the USA and Canada are off to a good start, we’re eagerly anticipating Germany’s regulatory green light for this study!”
Quarterly analyses will be performed with a board of MG international experts to provide insights on the experience of gMG patients in a real-world setting. These results will be regularly published and shared with the participants and their support groups, researchers and clinicians.
“Having already developed MSCopilot® for the monitoring of multiple sclerosis, we are now expanding our efforts to a new therapeutic area. This demonstrates our ability to scale up our innovative architecture”, according to Matthieu Lamy, Ad Scientiam’s president.
About ME&MGopen: The ME&MGopenTM smartphone application is an investigational software for research purposes developed by Ad Scientiam. Collaboratively designed and developed with input from patients, patient support organizations and medical experts in Myasthenia Gravis, it features digital tests to collect data on the respiratory capacity (“My Breathing” Test), dysarthria (“My Voice” Test), ptosis (“My Eyelids” test), as well as upper and lower limb muscle function (“My Arms” Test and “My Legs” Test). The mobile app also includes e-questionnaires related to daily activities, pain, insomnia, quality of life and depression. The objectives of the ME&MGopen study are to collect data on patients’ symptoms with the application in a real-world setting, to assess adherence, user experience and satisfaction with the application and its safety of use.
Check ME&MGopen Instagram and Facebook pages or visit meandmgopen.com
About Ad Scientiam: We strongly believe that continuously monitoring the progression of severe and disabling diseases in real-life is crucial for delivering better care. To achieve this, we create and clinically validate digital biomarkers that make these previously undetectable changes visible. These biomarkers are developed from data collected by digital tools such as smartphones and are transformed using proprietary algorithms. We have gained the trust of hospital institutions such as the Paris Brain Institute (ICM) and pharmaceutical companies including Biogen, Janssen, Sanofi, Pfizer, Vertex, and Novartis. In 2019, we launched MSCopilot®, the first CE-marked software medical device for self-assessment of patients with multiple sclerosis. We are currently validating new devices in neuroscience, rare diseases, and mental disorders. Ad Scientiam’s Quality Management System is in compliance with ISO 13485.
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