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

April 10, 2024 updated by: Zambon SpA

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1235

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Berlin, Germany
        • Praxis Dr. med. Kirsten Hahn
  • Italy
      • Chieti, Italy
        • Università degli Studi G. D'Annunzio
  • Spain
      • Sabadell, Spain
        • Corporacio Sanitaria Parc Tauli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Primary care clinic

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Group 1
500 patients already receiving safinamide (50 or 100 mg/day) as add-on to L-dopa for no more than 2 months.
Group 2
500 patients receiving rasagiline 1 mg/day as add-on to L-dopa for no more than 2 months.
Group 3
235 patients receiving other SoC drugs as add-on to L-dopa for no more than 2 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change from baseline to the end of study of the PDQ-39 total score.
Time Frame: The validated PDQ-39 assesses health-related quality improvement (Qi); an improvement in Qi corresponds to a decrease of the PDQ-39 total score.
Over a period of 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
PDQ-39 total score
Time Frame: 6 months
The change from baseline to 6 months in the PDQ-39 total score.
6 months
PDQ-39 sub-scores (domains and single items)
Time Frame: 6 and 12 months
The change from baseline to 6 months and to the end of study (12 months) in the PDQ-39 sub-scores (domains and single items)
6 and 12 months
UPDRS III score
Time Frame: 6 and 12 months
The change from baseline to 6 months and to the end of study (12 months) in the UPDRS III score.
6 and 12 months
NRS.
Time Frame: 6 and 12 months
The change from baseline to 6 months and to the end of study (12 months) in the NRS
6 and 12 months
anti-Parkinson drugs number
Time Frame: 6 and 12 months
The change in anti-Parkinson drugs number from baseline to 6 months and to the end of the study (12 months).
6 and 12 months
new anti-Parkinson drugs
Time Frame: 6 and 12 months
The introduction of new anti-Parkinson drugs, withdrawal, augmentation and decrease at 6 and 12 months, respectively.
6 and 12 months
The use of concomitant pain-killer medications
Time Frame: 6 and 12 months
The use of concomitant pain-killer medications at 6 and 12 months, respectively.
6 and 12 months
number of pain-killer medications
Time Frame: 6 and 12 months
The change in the number of pain-killer medications from baseline to 6 months and to the end of the study (12 months).
6 and 12 months
new pain-killer medications and daily dosage of pain-killer medications
Time Frame: 6 and 12 months
The introduction of new pain-killer medications, withdrawal, augmentation, decrease and daily dosage of pain-killer medications at 6 and 12 months, respectively.
6 and 12 months
Healthcare resources
Time Frame: 6 and 12 months
The use of healthcare resources from baseline to 6 months and to the end of study (12 months): number of and reason for hospitalizations, number of hospitalization days, number of visits to the emergency room, number of visits to PD specialists, number of diagnostic exams, number of rehabilitation visits.
6 and 12 months
number of working-days lost
Time Frame: 6 and 12 months
The number of working-days lost from baseline to 6 months and to the end of study (12 months).
6 and 12 months
Safety Endpoints
Time Frame: 6 and 12 months
The nature, frequency, severity, relationship (to study drug), actions taken, and outcome of adverse events (AEs) and serious adverse events (SAEs).
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zambon SpA

Collaborators

Iqvia Pty Ltd

Investigators

  • Study Director: Carlo Cattaneo, Zambon Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2019

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

June 18, 2019

First Submitted That Met QC Criteria

June 18, 2019

First Posted (Actual)

June 21, 2019

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z7219N04

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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