Survey Among Healthcare Professionals and MS Patients to Assess Their Understanding of RMP Materials

December 17, 2025 updated by: Novartis Pharmaceuticals

Survey Among Healthcare Professionals and MS Patients/Caregivers in Selected European Countries to Evaluate the Knowledge Required for the Safe Use of Mayzent

Survey to be completed independently by HCPs (neurologists treating patients with MS and MS specialist nurses) and patients/caregivers.

Study Overview

Status

Completed

Conditions

Detailed Description

The survey- based study was conducting amongst HCPs and patients/caregivers in selected European countries including Germany, Netherlands, Nordics (Denmark, Sweden), Spain and Croatia, plus Canada, to evaluate whether HCPs and patients/caregivers receive the educational materials and to capture their knowledge of specific Mayzent (siponimod) safety measures.

Study Type

Observational

Enrollment (Actual)

335

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

HCPs who prescribe, monitor and oversee the management / or provide in person medical supervision of patients on Mayzent (siponimod). And Patients/Caregivers of patients who are taking Mayzent (siponimod) to treat their MS and according to the prescription of their neurologists in selected EU countries

Description

Inclusion Criteria:

Physicians were considered eligible for the survey if they meet the following screening criteria:

  • Care for relapsing MS (RMS) patients
  • Personally prescribed disease modifying therapies to MS patients, and;
  • Have prescribed Mayzent (siponimod) in at least 1 SPMS patient.

Nurses were considered eligible for the survey if they:

  • Provide supportive care for RMS patients
  • Have initiated and/or managed the use of Mayzent (siponimod) in at least 1 SPMS patient.

Patient inclusion criteria include:

- Had initiated onto Mayzent (siponimod) to treat their MS since reimbursement

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Health Care Professionals (HCPs)
HCPs who prescribe, monitor and oversee the management / or provide in person medical supervision of patients on Mayzent (siponimod).
Patients/Caregivers
Patients/Caregivers of patients who are taking Mayzent (siponimod) to treat their MS and according to the prescription of their neurologists across EU countries and Canada that were included in the launch program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of HCPs and patients/caregivers who report receive and reading of the educational materials.
Time Frame: Throughout study completion, an average of 3 years
Percentage of HCPs and patients/caregivers who report receive and reading of the educational materials to be collected
Throughout study completion, an average of 3 years
Knowledge and understanding of the HCPs as per detailed in the educational information provided
Time Frame: Throughout study completion, an average of 3 years

Knowledge and understanding of the HCPs as per detailed in the educational information provided relating to:

  • The appropriate initiation
  • Specific safety measures when treating patients with Mayzent (siponimod)
  • Steps when treating patients with sinus bradycardia, 1st/2nd degree AV block or history of myocardial infarction or health failure
  • Procedures for the management of infections, macular edema, skin malignancies and pregnancy considerations.
  • Steps in ophthalmology checklist, managing infection risk, pregnancy, liver function and skin examinations

Knowledge and understanding was measured according to the percentage of correct responses given across the sample, where 70% achieving the correct answer is deemed acceptable.
Throughout study completion, an average of 3 years
Knowledge and understanding of the patient/caregivers' as per detailed in the educational information provided
Time Frame: Throughout study completion, an average of 3 years

Knowledge and understanding of the patient/caregivers' as per detailed in the educational information provided relating to:

  • Specific safety measures when being treated with Mayzent (siponimod)
  • Side effects and potential risks

Knowledge and understanding was measured according to the percentage of correct responses given across the sample, where 70% achieving the correct answer is deemed acceptable.
Throughout study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2021

Primary Completion (Actual)

May 16, 2025

Study Completion (Actual)

May 16, 2025

Study Registration Dates

First Submitted

March 21, 2022

First Submitted That Met QC Criteria

March 21, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBAF312A2006
  • EUPAS44782 (Other Identifier: EU PAS number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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