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

Parkinson's Disease Clinical Trial

— SUCCESS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03994328
• Other study ID #: Z7219N04
• Status: Completed
• Start date: December 3, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2024
• Source: Zambon SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1235
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
Germany	Praxis Dr. med. Kirsten Hahn	Berlin
Italy	Università degli Studi G. D'Annunzio	Chieti
Spain	Corporacio Sanitaria Parc Tauli	Sabadell

Sponsors (2)

Lead Sponsor	Collaborator
Zambon SpA	Iqvia Pty Ltd

Countries where clinical trial is conducted

Germany,  Italy,  Spain, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Drugs. 2014 Jul;74(11):1305. — View Citation

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. — View Citation

ISPE. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf. 2008 Feb;17(2):200-8. doi: 10.1002/pds.1471. No abstract available. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PDQ-39 total score	The change from baseline to 6 months in the PDQ-39 total score.	6 months
Secondary	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)	6 and 12 months
Secondary	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
Secondary	NRS.	The change from baseline to 6 months and to the end of study (12 months) in the NRS	6 and 12 months
Secondary	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
Secondary	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
Secondary	The use of concomitant pain-killer medications	The use of concomitant pain-killer medications at 6 and 12 months, respectively.	6 and 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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