Multiple SclerosisNCT05301907
Survey Among Healthcare Professionals and MS Patients to Assess Their Understanding of RMP Materials
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 1 site in Switzerland.
Trial summary
Survey to be completed independently by HCPs (neurologists treating patients with MS and MS specialist nurses) and patients/caregivers. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 335 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Dec 2021to 16 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, MS, NIS, survey
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Percentage of HCPs and patients/caregivers who report receive and reading of the educational materials.
Percentage of HCPs and patients/caregivers who report receive and reading of the educational materials to be collected
Measured: Throughout study completion, an average of 3 years
Knowledge and understanding of the HCPs as per detailed in the educational information provided
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.
Measured: Throughout study completion, an average of 3 years
Knowledge and understanding of the patient/caregivers' as per detailed in the educational information provided
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.
Measured: Throughout study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start2 Dec 2021
- Primary completion16 May 2025
- Study completion16 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301907
- Sponsor's protocol ID
- CBAF312A2006
- Other IDs
- EUPAS44782
- Status last verified
- Dec 2025
- First submitted
- 21 Mar 2022
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey Among Healthcare Professionals and MS Patients/Caregivers in Selected European Countries to Evaluate the Knowledge Required for the Safe Use of Mayzent
- ClinicalTrials.gov ID
- NCT05301907
- Acronym / sponsor ID
- CBAF312A2006
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, MS, NIS, survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 16 May 2025 (actual)
- Study completion
- 16 May 2025 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (9 listed)
- 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.
- Provide supportive care for RMS patients
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Link to study resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.