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

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ClinicalTrials.gov Identifier: NCT03994328
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : April 20, 2020
Sponsor:
Collaborator:
Iqvia Pty Ltd
Information provided by (Responsible Party):
Zambon SpA

Tracking Information
First Submitted Date June 18, 2019
First Posted Date June 21, 2019
Last Update Posted Date April 20, 2020
Actual Study Start Date December 3, 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 18, 2019)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 16, 2020)
  • PDQ-39 total score [ Time Frame: 6 months ]
    The change from baseline to 6 months in the PDQ-39 total score.
  • 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)
  • 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.
  • 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
  • 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).
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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).
  • 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).
Original Secondary Outcome Measures
 (submitted: June 18, 2019)
  • PDQ-39 total score [ Time Frame: 6 months ]
    The change from baseline to 6 months in the PDQ-39 total score.
  • 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)
  • 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.
  • 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
  • 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).
  • 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.
  • 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.
  • 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).
  • 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.
  • MMAS-8 score [ Time Frame: 6 and 12 months ]
    The change in the MMAS-8 score from baseline to 6 months and to the end of study (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.
  • 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).
  • 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Primary care clinic
Condition Parkinson's Disease
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 18, 2019)
1235
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Barbara Saccon +39 340 0638165 barbara.saccon@iqvia.com
Listed Location Countries Germany,   Italy,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03994328
Other Study ID Numbers Z7219N04
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Zambon SpA
Study Sponsor Zambon SpA
Collaborators Iqvia Pty Ltd
Investigators
Study Director: Carlo Cattaneo Zambon Group
PRS Account Zambon SpA
Verification Date April 2020