An Observational Study on Safinamide, Rasagiline and Other Standard of Care in PD (SUCCESS)
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| ClinicalTrials.gov Identifier: NCT03994328 |
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Recruitment Status :
Recruiting
First Posted : June 21, 2019
Last Update Posted : April 20, 2020
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| Condition or disease |
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| Parkinson's Disease |
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 |
| 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 |
| Group/Cohort |
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Group 1
500 patients already receiving safinamide (50 or 100 mg/day) as add-on to L-dopa for no more than 2 months.
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Group 2
500 patients receiving rasagiline 1 mg/day as add-on to L-dopa for no more than 2 months.
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Group 3
235 patients receiving other SoC drugs as add-on to L-dopa for no more than 2 months.
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- 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
- 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).
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
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
| Contact: Barbara Saccon | +39 340 0638165 | barbara.saccon@iqvia.com |
| 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 | |
| Study Director: | Carlo Cattaneo | Zambon Group |
| 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 |
| Studies a U.S. FDA-regulated Device Product: | No |
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Parkinson's PD Safinamide Rasagiline Levodopa L-DOPA Fluctuating Patients |
Add-on Therapy PDQ UPDRS NRS quality of life observational |
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Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |