PIRLONG-PD Safety and Efficacy of Piribedil in Parkinson's Disease During Long Term Therapy

NCT01519856 — Completed, 908 participants, Desitin Arzneimittel GmbH

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Efficacy and Safety of Long-term Therapy With Piribedil (CLARIUM) in Patients With M. Parkinson Under Consideration of Quality of Life Parameters and Cognitive Function

Registry	NCT01519856, acronym PIR-008/K
Status	Completed
Study type	Observational
Enrollment	908 (Actual)
Sponsor	Desitin Arzneimittel GmbH (Industry)
Conditions	Parkinson's Disease
Interventions	piribedil (Clarium) (Drug)
Dates	start 2009-06-01, primary completion 2014-12-01, completion 2015-02-01, first posted 2012-01-27, last updated 2016-01-29
Locations	1 site in Germany

-Summary

Non-Ergot Dopamine agonists are meanwhile the drugs of first-choice in the treatment of Parkinson's disease. The receptor profile of the non-ergot dopamine-agonist piribedil is unique. In addition to agonistic effects on dopaminergic D2- and D3-receptors piribedil has adrenergic alpha-2A- and alpha-2C-receptors antagonisic properties. There is evidence from the literature that the antagonistic properties of piribedil are correlated with an improvement of cognitive function and vigilance parameters in parkinson's disease. The aim of the present non-interventional study is to investigate the safety and efficacy of piribedil during long-term therapy of patients with M. Parkinson under consideration of cognitive functions and quality of life.

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+Arms and interventions

Arm	Type	Interventions	Description
tablet		Drug: piribedil (Clarium)

piribedil (Clarium) (Drug): oral tablets, 50 mg

+Outcome measures

Primary outcomes

Adverse event profile during long term therapy with piribedil in patients with Parkinson's disease [4 years]

Secondary outcomes

Influence on quality of life [4 years]
Quality of life parameters [4 years]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* newly diagnosed or advanced idiopathic Parkinson's disease
* male and female patients over 18 years of age
* indication for treatment with piribedil according to Summary of Product Characteristics (SmPC)

Exclusion Criteria:

* in line with piribedil SmPC
* in particular hypersensitivity to piribedil or to any of the excipients and pregnancy and lactation as stated in the SmPC

+Locations (1)

Facility	City	Country	Status
Dr. Erich Scholz	Böblingen, Baden-Wurttemberg	Germany

+Publications

Castro-Caldas A, Delwaide P, Jost W, Merello M, Williams A, Lamberti P, Aguilar M, Del Signore S, Cesaro P; Parkinson-Control Study Group. The Parkinson-Control study: a 1-year randomized, double-blind trial comparing piribedil (150 mg/day) with bromocriptine (25 mg/day) in early combination with levodopa in Parkinson's disease. Mov Disord. 2006 Apr;21(4):500-9. doi: 10.1002/mds.20750. PMID 16267842
Rascol O, Dubois B, Caldas AC, Senn S, Del Signore S, Lees A; Parkinson REGAIN Study Group. Early piribedil monotherapy of Parkinson's disease: A planned seven-month report of the REGAIN study. Mov Disord. 2006 Dec;21(12):2110-5. doi: 10.1002/mds.21122. PMID 17013922
Peretti CS, Gierski F, Harrois S. Cognitive skill learning in healthy older adults after 2 months of double-blind treatment with piribedil. Psychopharmacology (Berl). 2004 Nov;176(2):175-81. doi: 10.1007/s00213-004-1869-8. Epub 2004 May 12. PMID 15138753
Schuck S, Bentue-Ferrer D, Kleinermans D, Reymann JM, Polard E, Gandon JM, Allain H. Psychomotor and cognitive effects of piribedil, a dopamine agonist, in young healthy volunteers. Fundam Clin Pharmacol. 2002 Feb;16(1):57-65. doi: 10.1046/j.1472-8206.2002.00070.x. PMID 11903513