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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease
Parkinson's Disease

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.

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Study Type : Observational
Estimated Enrollment : 1235 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : December 3, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. PDQ-39 total score [ Time Frame: 6 months ]
    The change from baseline to 6 months in the PDQ-39 total score.

  2. 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)

  3. 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.

  4. 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

  5. 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. 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.

  7. 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.

  8. 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).

  9. 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.

  10. 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.

  11. 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).

  12. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care clinic
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994328


Contacts
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Contact: Barbara Saccon +39 340 0638165 barbara.saccon@iqvia.com

Locations
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Germany
Praxis Dr. med. Kirsten Hahn Recruiting
Berlin, Germany
Contact: Kirsten Hahn, Dr. med.    3049918191 ext 49    hahnkirsten@gmail.com   
Italy
Università degli Studi G. D'Annunzio Recruiting
Chieti, Italy
Contact: Astrid Thomas, Prof.    0871 562019 ext 39    astrid.thomas@unich.it   
Spain
Corporacio Sanitaria Parc Tauli Recruiting
Sabadell, Spain
Contact: Tania Delgado, Dr.    937231010 ext 34    tdelgado@tauli.cat   
Sponsors and Collaborators
Zambon SpA
Iqvia Pty Ltd
Investigators
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Study Director: Carlo Cattaneo Zambon Group
Publications:

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Responsible Party: Zambon SpA
ClinicalTrials.gov Identifier: NCT03994328    
Other Study ID Numbers: Z7219N04
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zambon SpA:
Parkinson's
PD
Safinamide
Rasagiline
Levodopa
L-DOPA
Fluctuating Patients
Add-on Therapy
PDQ
UPDRS
NRS
quality of life
observational
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases