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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/44783
• EU PAS number:
  EUPAS44782
• Study ID:
  44783
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  Croatia

  Denmark

  Germany

  Netherlands

  Spain

  Sweden
• Study description:
  The objective of this survey is to evaluate whether HCPs and patients/caregivers receive the educational materials and to capture their knowledge of specific Mayzent (siponimod) safety measures. The web-based survey will be conducted in some EU countries and Canada where Mayzent (siponimod) is available on the market and reimbursed for at least 6 months, to capture the knowledge and understanding of specific Mayzent safety measures by HCPs and patients/caregivers with access to Mayzent (siponimod). A total sample of N=220 completed surveys from HCPs (160 neurologists treating patients with MS and 60 MS specialist nurses) and N=115 completed surveys from patients/caregivers will take part.
• Study status:
  Ongoing

Research institution and networks

Institutions

Novartis Pharmaceuticals

Study timelines

Date when funding contract was signed

Planned: 27/05/2020

Actual: 27/05/2020

Study start date

Planned: 31/10/2021

Actual: 02/12/2021

Data analysis start date

Planned: 30/09/2024

Date of final study report

Planned: 30/09/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis Pharmaceutical SA

Study protocol

Initial protocol

CBAF312A2006-Amended protocol v1.4_Clean version_29Mar2021_Redacted

Updated protocol

CBAF312A2006_ProtocolAmendment_V3_25Jan2024_Clean Version_Redacted.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

CBAF312A2006

Link to Clinicaltrials.gov