Survey among healthcare professionals (neurologists treating patients with MS along with MS specialist nurses) and patients in selected European countries plus Canada to evaluate the knowledge required for the safe use of Mayzent (siponimod)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Evaluation of patient-reported outcomes

  Other
• If ‘other’, further details on the scope of the study:
  Evaluation education materials
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Multinational, questionnaire-based, cross-sectional survey to be conducted among 1) healthcare professionals and 2) patients/caregivers

Study drug and medical condition

• Medicinal product name:
  MAYZENT
• Study drug International non-proprietary name (INN) or common name:
  SIPONIMOD
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AE03) siponimod

  siponimod
• Medical condition to be studied:
  Multiple sclerosis

Population studied

• Short description of the study population:
  The study was conducted across two populations:; 1. HCPs who prescribe, monitor and oversee the management / or provide in person medical ; supervision of patients on Mayzent (siponimod). These included treating physicians as well as ; MS specialist nurses ; 2. Patients/Caregivers of patients who are taking Mayzent (siponimod) to treat their MS and ; according to the prescription of their neurologists
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
• Estimated number of subjects:
  335

Study design details

• Study design:
  The study included two distinct questionnaires
• Main study objective:
  The objective of this survey was to evaluate whether HCPs and patients/caregivers received the educational materials and to capture their knowledge of specific Mayzent (siponimod) safety measures.
• Setting:
  The survey was administered in six European markets that represent distribution and prevalence of MS ; and where Mayzent (siponimod) was available and reimbursed for at least six months (Germany, ; Netherlands, Spain, Croatia, Sweden and Denmark), and Canada.
• Data analysis plan:
  The analysis was descriptive in nature. For continuous variables, counts, means (with standard deviations), medians and ranges were provided. For categorical variables, frequencies and percentages (with 95% confidence intervals) were provided. Missing data was noted for each variable.