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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study summary

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 336 MS patients and will be conducted in the United States, Canada, Germany, Italy, Spain, Denmark and France

Eligibility

Primary outcome measure(s)

• To evaluate MSCopilot® Detect individual scores and/or composite scores sensitivity to detect disability worsening based on revised-MSFC scores. — Throughout the study at each hospital visit: Day 0, Month 6, Month 12, Month 18 and Month 24 (if applicable)
  The discriminatory ability of the MSCopilot® Detect application in detecting clinically meaningful worsening (disability worsening) based on the revised-MSFC will be evaluated using the Area Under the ROC Curve (AUC) method. Confidence intervals will also be estimated. The minimum significant AUC value will be set at \>0.67, and Confidence Intervals will be calculated. Sensitivity and specificity will also be determined. To validate the estimated AUC values and cutoffs generated by the MSCopilot® Detect application, a train/test set will be utilised.

Trial sites (34)

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