Multiple Sclerosis Clinical Trial

MS-DETECT: Early Detection of Multiple Sclerosis Progression With MSCopilot®

Summary

The study aims to evaluate MSCopilot®, a smartphone application for at-home monitoring of patients with Multiple Sclerosis (MS).

The primary objective is to enhance and standardize remote monitoring of MS patients to accurately assess disease progression caused by either Relapse Activity Worsening (RAW) or Progression Independent of Relapses (PIRA). The study also aims to assess the safety, usability, and satisfaction of the solution.

A secondary objective is to determine MSCopilot®'s ability to provide early detection of disease changes and predict changes in Expanded Disability Status Scale (EDSS) scores in more patients.

Exploratory objectives include evaluating the relationship between MSCopilot® composite and individual scores and other biomarkers such as MRI, soluble glial fibrillary acidic protein (sGFAP), and soluble neurofilament light chain (sNfL).

Patients will be able to download the free MSCopilot® app. They will participate in 1 inclusion visit and 3 follow-up visits, scheduled at 6 months, 12 months, and 18 months (an additional visit at 24 months may be scheduled if necessary). Every 3 months, patients will complete validated questionnaires regarding MS symptoms and quality of life and participate in digital tests designed to monitor MS symptom progression.

The study will include 243 MS patients and will be conducted in the United States, Canada, Germany, Italy, Spain, Denmark and France

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Adult patients living with RRMS and SPMS, aged 30 to 65
EDSS score between 2.5 to 6.5 points
With a disease duration > 5 years
Clinically stable during the last 3 months before inclusion (no relapses, no disability progression)
No change in the DMT* during the last 3 months before inclusion
Receiving optimal symptomatic treatments at baseline (clinician's judgment)
Owns a personal smartphone which mobile operating system is above 14 for IOS (iPhone) and 8 for Android included with a good internet connexion

Exclusion Criteria:

Any medically unstable condition that may interfere with the patient's ability to cooperate and comply with the study procedures
Inability to use a smartphone or MSCopilot application
Pregnancy and nursing women
Persons under guardianship or curatorship
Current drugs or/and alcohol abuse that could influence performance on the tests (clinician's judgment)
Patients have participated in another clinical study within the previous 30 days of screening or are currently participating in another study that, in the opinion of the Investigator, might interfere with the patient's full participation in the study or confound the assessment of the patient or outcome of the study.

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

243

Study ID:

NCT05816122

Recruitment Status:

Not yet recruiting

Sponsor:

Ad scientiam

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Oklahoma Medical Research Foundation,
Oklahoma City Oklahoma, 73104, United States More Info
Gabriel Pardo, Dr.
Contact
St. Michael's Hospital
Toronto , , Canada More Info
Jiwon Oh, Prof.
Contact
University Hospital of Southern Denmark
Esbjerg , , Denmark More Info
Tobias Sejbaek, Dr.
Contact
Hôpital Roger Salengro
Lille , , France More Info
Patrick Vermersch, Prof.
Contact
Universitätsklinikum Carl Gustav Carus
Dresden , , Germany More Info
Tjalf Ziemssen, Prof.
Contact
IRCCS Ospedale San Raffaele
Milan , , Italy More Info
Massimo Filippi, Prof.
Contact
University Hospital San Carlos
Madrid , , Spain More Info
Celia Oreja-Guevara, Prof.
Contact

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

243

Study ID:

NCT05816122

Recruitment Status:

Not yet recruiting

Sponsor:


Ad scientiam

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.