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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05301907
• Other study ID #: CBAF312A2006
• Secondary ID: EUPAS44782
• Status: Recruiting
• Start date: December 2, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

The survey- based study is 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 335
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Physicians will be 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 will be 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:

• Have been initiated onto Mayzent (siponimod) to treat their MS since reimbursement

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
Switzerland	Novartis Investigative Site	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Throughout study completion, an average of 3 years
Primary	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 will be 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
Primary	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 will be 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