An Observational Study on Safinamide, Rasagiline and Other Standard of Care in PD
NCT ID: NCT03994328
Last Updated: 2024-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1235 participants
OBSERVATIONAL
2019-12-03
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Group 2
500 patients receiving rasagiline 1 mg/day as add-on to L-dopa for no more than 2 months.
No interventions assigned to this group
Group 3
235 patients receiving other SoC drugs as add-on to L-dopa for no more than 2 months.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Iqvia Pty Ltd
INDUSTRY
Zambon SpA
INDUSTRY
Responsible Party
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Principal Investigators
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Carlo Cattaneo
Role: STUDY_DIRECTOR
Zambon Group
Locations
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Praxis Dr. med. Kirsten Hahn
Berlin, , Germany
Università degli Studi G. D'Annunzio
Chieti, , Italy
Corporacio Sanitaria Parc Tauli
Sabadell, , Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
ISPE. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf. 2008 Feb;17(2):200-8. doi: 10.1002/pds.1471. No abstract available.
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.
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.
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.
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.
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.
Other Identifiers
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Z7219N04
Identifier Type: -
Identifier Source: org_study_id
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