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

NCT03994328 | Completed

• 1 other identifier: Z7219N04
• Study Type: observational
• Target: 1,235
• Locations: 3 countries
• Sites: 3

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's; PD; Safinamide; Rasagiline; Levodopa; L-DOPA; Fluctuating Patients; Add-on Therapy; PDQ; UPDRS; NRS; quality of life; observational

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (12)

• PDQ-39 total score

  6 months

• PDQ-39 sub-scores (domains and single items)

  6 and 12 months

• UPDRS III score

  6 and 12 months

• NRS.

  6 and 12 months

• anti-Parkinson drugs number

  6 and 12 months

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary care clinic

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zambon SpA: lead
• Iqvia Pty Ltd: collaborator

Study Sites (3)

Praxis Dr. med. Kirsten Hahn

Berlin, Germany

Location

Università degli Studi G. D'Annunzio

Chieti, Italy

Location

Corporacio Sanitaria Parc Tauli

Sabadell, Spain

Location

Related Publications (14)

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  PMID: 28332488 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.

  PMID: 23917951 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.

  PMID: 21626386 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.

  PMID: 24756517 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.

  PMID: 17427940 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.

  PMID: 19375664 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.

  PMID: 29853294 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.

  PMID: 17030736 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.

  PMID: 17868186 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.

  PMID: 6067254 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.

  PMID: 7613534 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.

  PMID: 21856077 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.

  PMID: 18453793 BACKGROUND

• 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.

  PMID: 35148289 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Carlo Cattaneo

  Zambon Group

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 21, 2019
• Study Start: December 3, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

DE (1); IT (1); ES (1)