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

Zambon

Status: Completed

Conditions: Parkinson's Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT03994328

Z7219N04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,235 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,235 participants in 3 patient groups

Group 1

Description:

500 patients already receiving safinamide (50 or 100 mg/day) as add-on to L-dopa for no more than 2 months.

Group 2

Description:

500 patients receiving rasagiline 1 mg/day as add-on to L-dopa for no more than 2 months.

Group 3

Description:

235 patients receiving other SoC drugs as add-on to L-dopa for no more than 2 months.