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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05301907
Enrollment
335
Registered
2022-03-31
Start date
2021-12-02
Completion date
2025-05-16
Last updated
2025-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, MS, NIS, survey

Brief summary

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

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.

Interventions

None listed

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Percentage of HCPs and patients/caregivers who report receive and reading of the educational materials.Throughout study completion, an average of 3 yearsPercentage of HCPs and patients/caregivers who report receive and reading of the educational materials to be collected
Knowledge and understanding of the HCPs as per detailed in the educational information providedThroughout study completion, an average of 3 yearsKnowledge 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.
Knowledge and understanding of the patient/caregivers' as per detailed in the educational information providedThroughout study completion, an average of 3 yearsKnowledge 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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026