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Clinnova-MS: A Prospective Cohort Study of Patients With Multiple Sclerosis (Switzerland)

NCT06526364 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-12-26

No results posted yet for this study

Summary

This prospective cohort study is part of the Clinnova programme and aims to (i) identify clinical imaging and omics characteristics associated with early Multiple Sclerosis (MS) and with transitioning phases to progressive MS, as well as (ii) to investigate digital biomarkers allowing the continuous clinical monitoring of those patients.

Conditions

  • Multiple Sclerosis
  • Multiple Sclerosis, Relapsing-Remitting
  • Multiple Sclerosis, Primary Progressive
  • Multiple Sclerosis, Secondary Progressive

Interventions

OTHER

All participants will be asked to provide data and samples for collection and analysis.

During the first year, data related to demographics, lifestyle, clinical examinations will be collected at baseline, at 6 months (optional) and at 12 months. PROs, cognitive and motor assessments will be performed using the Healios+Me smartphone app. Additionally, participants will be asked to provide biological samples (i.e., blood, cerebrospinal fluid and stool, saliva and hair) and imaging data (if performed as per standard of care). One unscheduled visit may be performed in case the participant comes to the hospital with the occurrence of flare or for a treatment change. A long-term follow-up (FU, starting from month 12 and up to 4 years after month 12) is foreseen in this study. During the long-term FU medical data are collected either every 6 month or on a yearly basis, and PROs are collected every 6 months. Whether study visits are conducted in 6- or 12-monthly intervals depends on the schedule of the study visits for the Swiss MS cohort (SMSC).

Sponsors & Collaborators

  • Luxembourg Institute of Health

    collaborator OTHER_GOV

  • Research Center for Clinical Neuroimmunology and Neuroscience Basel

    collaborator OTHER

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Cristina Granziera, Prof. · Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-10
Primary Completion
2029-06-30
Completion
2029-06-30

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06526364 on ClinicalTrials.gov