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OpenTrials
Completed

NCT Number: NCT05301907

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

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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site

Basel, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 31, 2022
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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