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

Study Purpose

The study aims to evaluate MSCopilot® Detect, 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® Detect'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® Detect 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® Detect 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 314 MS patients and will be conducted in the United States, Canada, Germany, Italy, Spain, Denmark and France

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	30 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Adult patients living with RRMS or 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.

- Able to use a smartphone.

- Able to read language in wich the mobile application is available and able to understand pictograms.

- Applicable to patients enrolled in France only: affiliated to a social security system.

Exclusion Criteria:

- Medically unstable conditions that may hinder patient's ability to comply with the study procedures.

- Inability to use a smartphone or MSCopilot® Detect application.

- Patient with corrected visual acuity less than 4/10 (Monoyer) or 20/50 (Snellen at 20 feet) or +0,4 (LogMAR) - 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05816122
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Ad scientiam
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Canada, Denmark, France, Germany, Italy, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis

Arms & Interventions

Arms

Experimental: MSCopilot® Detect

Performance of digital tests and standard test in clinic at D0, M6, M12, M18 and M24 (if applicable) Use of MSCopilot® Detect at-home in between visits during 18 or 24 months (if applicable)

Interventions

Device: - MSCopilot® Detect mobile application

MSCopilot® Detect includes active tests for walking, cognition, dexterity and vision, and e-questionnaires related to fatigue and Multiple Sclerosis quality of life

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Joash Lazarus Sr., Atlanta, Georgia

Status

Not yet recruiting

Address

Joash Lazarus Sr.

Atlanta, Georgia, 30327

Site Contact

Joash Lazarus, Dr

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