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

Parkinson's Disease Clinical Trial

— PIR-008/K  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01519856
• Other study ID #: PIR-008/K
• Status: Completed
• Phase: N/A
• First received: March 12, 2010
• Last updated: January 28, 2016
• Start date: June 2009
• Est. completion date: February 2015

Study information

• Verified date: July 2015
• Source: Desitin Arzneimittel GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 908
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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

Locations

Country	Name	City	State
Germany	Dr. Erich Scholz	Boeblingen	Baden-Wuertemberg

Sponsors (1)

Lead Sponsor	Collaborator
Desitin Arzneimittel GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View Citation

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. Epub 2004 May 12. — View Citation

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. — View Citation

Schück S, Bentué-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event profile during long term therapy with piribedil in patients with Parkinson's disease		4 years	Yes
Secondary	Influence on quality of life		4 years	Yes
Secondary	Quality of life parameters		4 years	Yes