For Healthcare Professionals

An Observational Study on Safinamide, Rasagiline and Other Standard of Care in PD

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About the study

The purpose of this study 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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Patients of both genders ≥ 18 years of age, with a clinical diagnosis of idiopathic PD according to UK Brain Bank diagnostic criteria (12) for whom safinamide, rasagiline or any other anti-Parkinson drugs are prescribed according to the current Summary of Product Characteristics (SmPC).
  2. Willing to participate in the study and able to understand and sign the written informed consent form.
  3. Patients on a stable anti-Parkinson therapy, always including L-dopa + dopa-decarboxylase inhibitor (DDI), with or without other anti-Parkinson medications.
  4. Patients must be treated with safinamide, rasagiline or other SoC drugs as add-on to L-dopa for no more than 2 months prior to the baseline visit, according to the clinical practice.

EXCLUSION CRITERIA

  1. Patients with any form of Parkinsonism other than idiopathic PD.
  2. Patients for whom safinamide, rasagiline or any other anti-Parkinson drug are contraindicated according to the current SmPC.
  3. Patients known to be pregnant.
  4. Patients treated with safinamide or rasagiline who receive other concomitant MAO-B inhibitors.
  5. Patients treated with other SoC drugs who receive safinamide or rasagiline.
  6. Previous participation in a clinical trial with an investigational drug or medical device in the 3 months prior to the baseline visit.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +39 340 0638165Email iconEmail Study Center

Study’s details


Contition

Parkinson's Disease

Age (in years)

18 - 200

Participants needed

1235

Est. Completion Date

Apr 2024

Treatment type

Observational


Sponsor

Zambon SpA

ClinicalTrials.gov identifier

NCT03994328

Study number

Z7219N04

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