European multicenter retrospective-prospective cohort study to observe Safinamide safety profile and pattern of use in clinical practice during the first post-commercialization phase - Study Z7219N02 (SYNAPSES)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Safety study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  SAFINAMIDE METHANESULFONATE
• Medical condition to be studied:
  Parkinson's disease

Population studied

• Short description of the study population:
  Adult patients treated with Safinamide according to clinical practice will be consecutively enrolled in each participating site during the 24-month recruitment period.; ; Inclusion criteria (at enrolment visit):; 1. Adult male and female patients (≥18 years).; 2. Patients who start treatment with Safinamide at enrolment visit or who started it in the previous 4 months, according to clinical practice after its commercialization. This is an observational study, hence physician’s decision of starting treatment with Safinamide has been taken before the patient inclusion in the study and is completely independent from the study protocol.; 3. Patients who have signed informed and privacy form consent according to local legal requirement.; ; Exclusion criteria (at enrolment visit):; 1. Patients participating in any clinical trial on Safinamide at study inclusion
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Parkinson's disease patients
• Estimated number of subjects:
  1600

Study design details

• Main study objective:
  To observe Safinamide safety profile and pattern of use in clinical practice during the first post-commercialization phase.
• Outcomes:
  To describe the occurrence of adverse events in patients treated with Safinamide in real-life conditions during 1 year in the first post-commercialization phase as reported by the Investigators. To describe the characteristics of patients treated with Safinamide according to clinical practice (demographics, disease duration, disease severity, previous treatment for PD, concomitant relevant conditions with particular focus on psychiatric ones and related treatments).To describe Safinamide treatment patterns in real-life setting (treatment duration, dose adjustments and interruptions.
• Data analysis plan:
  Data will be described on all enrolled patients fulfilling inclusion/ exclusion criteria.Patients with missing values will not be excluded from the analysis, but their data will not be replaced, frequency of missing data will be given for all analyzed variables.The aim of the study is merely descriptive and there are no pre-specified hypotheses.Categorical variables will be described by means of absolute and relative frequencies, while continuous variables by means of mean, standard deviation, quartiles, min and max.