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 identification

• EU PAS number:
  EUPAS41248
• Study ID:
  41249
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  This is an observational, prospective, multinational, multicentre study. Adult patients treated with safinamide, rasagiline or other SoC medications according to clinical practice and meeting the inclusion/exclusion criteria will be consecutively enrolled in each participating site. Study participation will be up to a maximum duration of approximately 12 months and will comprise three visits: a baseline visit at the start of the observation period, a second visit, approximately 6-months later, and a final visit at the end of the observation period (approximately at 12 months). No visits or examinations, laboratory tests or procedures are mandated as part of this study. The visits will take place during routine clinical practice. During the study, patients may continue or change the treatment based on their physician’s medical judgement. The primary objective is 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.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Zambon

Study timelines

Date when funding contract was signed

Planned:19/09/2019

Actual:04/10/2019

Study start date

Planned:02/12/2019

Actual:05/12/2019

Date of final study report

Planned:30/09/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Zambon S.p.A.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable