NCT05816122

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 336 (actual)
• Sponsor: Ad scientiam · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-09-22
• Primary completion: 2027-05-31
• Completion: 2027-05-31
• First posted: 2023-04-18
• Last updated: 2025-06-13

Locations

34 sites across 7 countries: United States, Canada, Denmark, France, Germany, Italy, Spain

Regulatory

• FDA-regulated device study