NCT03994328Completed
An Observational Study on Safinamide, Rasagiline and Other Standard of Care in PD
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
Source: ClinicalTrials.gov · Last updated 11 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1235 (actual)
- First submitted
- 18 Jun 2019
- Start date
- 3 Dec 2019
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Zambon SpA
- Diseases
- Parkinson disease
- NCT number
- NCT03994328
What you commit to
- Study type: Observational
- Participants enrolled: 1235
- From 3 Dec 2019 to the primary completion date, 31 Dec 2023
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients for whom safinamide, rasagiline or any other anti-Parkinson drug are contraindicated according to the current SmPC.
- Patients treated with safinamide or rasagiline who receive other concomitant MAO-B inhibitors.
- Patients treated with other SoC drugs who receive safinamide or rasagiline.
- Previous participation in a clinical trial with an investigational drug or medical device in the 3 months prior to the baseline visit.
Other
- Patients with any form of Parkinsonism other than idiopathic PD.
- Patients known to be pregnant.
Who the study is looking for
- 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).
- Willing to participate in the study and able to understand and sign the written informed consent form.
- Patients on a stable anti-Parkinson therapy, always including L-dopa + dopa-decarboxylase inhibitor (DDI), with or without other anti-Parkinson medications.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Praxis Dr. med. Kirsten Hahn Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Corporacio Sanitaria Parc Tauli Coordinator of this site? Confirm its status | Sabadell | Spain | Unknown status |
| Università degli Studi G. D'Annunzio Coordinator of this site? Confirm its status | Chieti | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.