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| Name | Class |
|---|---|
| IQVIA Pty Ltd | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline to the end of study 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PDQ-39 total score | The change from baseline to 6 months in the PDQ-39 total score. | 6 months |
| PDQ-39 sub-scores (domains and single items) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Carlo Cattaneo | Zambon Group | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Praxis Dr. med. Kirsten Hahn | Berlin | Germany | ||||
| Università degli Studi G. D'Annunzio |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28332488 | Background | Poewe W, Seppi K, Tanner CM, Halliday GM, Brundin P, Volkmann J, Schrag AE, Lang AE. Parkinson disease. Nat Rev Dis Primers. 2017 Mar 23;3:17013. doi: 10.1038/nrdp.2017.13. | |
| 23917951 | Background | Fox SH. Non-dopaminergic treatments for motor control in Parkinson's disease. Drugs. 2013 Sep;73(13):1405-15. doi: 10.1007/s40265-013-0105-4. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 6 and 12 months |
| UPDRS III score | 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. | 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 | 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 | 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 | The use of concomitant pain-killer medications at 6 and 12 months, respectively. | 6 and 12 months |
| number of pain-killer medications | 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 | 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 | 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 | 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 | 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 |
| Chieti |
| Italy |
| Corporacio Sanitaria Parc Tauli | Sabadell | Spain |
| 21626386 | Background | Wirdefeldt K, Adami HO, Cole P, Trichopoulos D, Mandel J. Epidemiology and etiology of Parkinson's disease: a review of the evidence. Eur J Epidemiol. 2011 Jun;26 Suppl 1:S1-58. doi: 10.1007/s10654-011-9581-6. Epub 2011 May 28. |
| 24756517 | Background | Connolly BS, Lang AE. Pharmacological treatment of Parkinson disease: a review. JAMA. 2014 Apr 23-30;311(16):1670-83. doi: 10.1001/jama.2014.3654. |
| 17427940 | Background | Fabbrini G, Brotchie JM, Grandas F, Nomoto M, Goetz CG. Levodopa-induced dyskinesias. Mov Disord. 2007 Jul 30;22(10):1379-1389. doi: 10.1002/mds.21475. |
| 19375664 | Background | Chaudhuri KR, Schapira AH. Non-motor symptoms of Parkinson's disease: dopaminergic pathophysiology and treatment. Lancet Neurol. 2009 May;8(5):464-74. doi: 10.1016/S1474-4422(09)70068-7. |
| 29853294 | Background | Neff C, Wang MC, Martel H. Using the PDQ-39 in routine care for Parkinson's disease. Parkinsonism Relat Disord. 2018 Aug;53:105-107. doi: 10.1016/j.parkreldis.2018.05.019. Epub 2018 May 17. |
| 17030736 | Background | Caccia C, Maj R, Calabresi M, Maestroni S, Faravelli L, Curatolo L, Salvati P, Fariello RG. Safinamide: from molecular targets to a new anti-Parkinson drug. Neurology. 2006 Oct 10;67(7 Suppl 2):S18-23. doi: 10.1212/wnl.67.7_suppl_2.s18. |
| 17868186 | Background | ISPE. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf. 2008 Feb;17(2):200-8. doi: 10.1002/pds.1471. No abstract available. |
| 6067254 | Background | Hoehn MM, Yahr MD. Parkinsonism: onset, progression and mortality. Neurology. 1967 May;17(5):427-42. doi: 10.1212/wnl.17.5.427. No abstract available. |
| 7613534 | Background | Peto V, Jenkinson C, Fitzpatrick R, Greenhall R. The development and validation of a short measure of functioning and well being for individuals with Parkinson's disease. Qual Life Res. 1995 Jun;4(3):241-8. doi: 10.1007/BF02260863. |
| 21856077 | Background | Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005. |
| 18453793 | Background | Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008 May;10(5):348-54. doi: 10.1111/j.1751-7176.2008.07572.x. |
| 35148289 | Derived | Lawn T, Rukavina K, Malcangio M, Howard M, Chaudhuri KR. Response to Mylius et al. Pain. 2022 Mar 1;163(3):e496-e497. doi: 10.1097/j.pain.0000000000002445. No abstract available. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |