Clinical trial NCT03994328: An Observational Study on Safinamide, Rasagiline and Other Standard of Care in PD
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Parkinson's
PD
Safinamide
Rasagiline
Levodopa
L-DOPA
Fluctuating Patients
Add-on Therapy
PDQ
UPDRS
NRS
quality of life
observational
Lead sponsor: Zambon SpA
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2019-06-21
Enrollment: 1235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: 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.

Detailed description: Safinamide is an alpha-aminoamide derivative, structurally unrelated to any other drug for the treatment of PD, with a dual mechanism of action (dopaminergic and non-dopaminergic). In particular, it is a potent, selective and reversible MAO-B inhibitor, and it is a glutamate modulator through the sodium channels blockade.

Safinamide has been approved in Europe for the treatment of mid- to late-stage patients with idiopathic PD and fluctuations as add-on therapy to a stable dose of levodopa (alone or in combination with other PD medications).

Rasagiline is an irreversible MAO-B inhibitor, with unknown activity on other neurotransmitters. Rasagiline has been approved in Europe for the treatment of idiopathic PD as monotherapy or as add-on to levodopa in patients with end of dose fluctuations.

The aim of this observational study is to evaluate the effectiveness of safinamide, rasagiline and other "standard of care" (SoC) drugs when prescribed in clinical routine as add-on to L-dopa in terms of quality of life, improvement of chronic pain, change in Anti-Parkinson treatment (modification of doses, addition or withdrawal or other Anti-Parkinson drugs, etc.), use of concomitant pain-killer medications, compliance to the PD treatment, hospitalizations and use of other healthcare resources, and number of lost working days.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients with any form of Parkinsonism other than idiopathic PD.
* Patients for whom safinamide, rasagiline or any other anti-Parkinson drug are contraindicated according to the current SmPC.
* Patients known to be pregnant.
* 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.

Primary outcomes:
measure: The change from baseline to the end of study of the PDQ-39 total score.
timeFrame: The validated PDQ-39 assesses health-related quality improvement (Qi); an improvement in Qi corresponds to a decrease of the PDQ-39 total score.
Secondary outcomes:
measure: PDQ-39 total score
timeFrame: 6 months
measure: PDQ-39 sub-scores (domains and single items)
timeFrame: 6 and 12 months
measure: UPDRS III score
timeFrame: 6 and 12 months
measure: NRS.
timeFrame: 6 and 12 months
measure: anti-Parkinson drugs number
timeFrame: 6 and 12 months
measure: new anti-Parkinson drugs
timeFrame: 6 and 12 months
measure: The use of concomitant pain-killer medications
timeFrame: 6 and 12 months
measure: number of pain-killer medications
timeFrame: 6 and 12 months
measure: new pain-killer medications and daily dosage of pain-killer medications
timeFrame: 6 and 12 months
measure: Healthcare resources
timeFrame: 6 and 12 months
measure: number of working-days lost
timeFrame: 6 and 12 months
measure: Safety Endpoints
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Praxis Dr. med. Kirsten Hahn
city: Chieti
country: Italy
facility: Università degli Studi G. D'Annunzio
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
Study officials:
affiliation: Zambon Group
name: Carlo Cattaneo
role: STUDY_DIRECTOR
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