AN OBSERVATIONAL, PROSPECTIVE, MULTINATIONAL, MULTICENTRE STUDY COMPARING THE EFFECTIVENESS OF SAFINAMIDE, RASAGILINE AND OTHER “STANDARD OF CARE” AS ADD-ON THERAPY TO LEVODOPA (L-DOPA) IN PARKINSON’S DISEASE (PD) FLUCTUATING PATIENTS (SUCCESS)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  This is an observational, prospective, multinational, multicentre study.

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

• 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)
• Estimated number of subjects:
  1235

Study design details

• Main study objective:
  To evaluate how safinamide, rasagiline and other SoC drugs are associated with the quality of life of PD patients by means of the Parkinson’s Disease Questionnaire (PDQ)-39 items.
• Outcomes:
  The change from baseline to the end of study (12 months) in the PDQ-39 total score. • The change from baseline to 6 months in the PDQ-39 total score. • The change from baseline to 6 months and to the end of study (12 months) in the PDQ-39 sub-scores (domains and single items). • The change from baseline to 6 months and to the end of study (12 months) in the UPDRS III score. • The change from baseline to 6 months and to the end of study (12 months) in the NRS.
• Data analysis plan:
  The primary objective of the study is to evaluate the change from baseline to the end of the study (12 months) in the PDQ-39 total score. Because the treatments will not be randomly assigned to patients, potential confounding and selection biases will be addressed by developing a propensity score for each of the treatment in study (considering other SoC as a single group), using multinomial logistic regression with study treatment as dependent variable and a set of selected covariates (confounders) as independent variables. The propensity score calculated from the logistic analysis for each patient represents the probability that a patient would be treated with safinamide rather than with rasagiline, rather than with other SoC. The calculated propensity scores will be then used to compute weights for a weighted outcome analysis.