PIRLONG-PD Safety and Efficacy of Piribedil in Parkinson's Disease During Long Term Therapy (PIR-008/K)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Desitin Arzneimittel GmbH
ClinicalTrials.gov Identifier:
NCT01519856
First received: March 12, 2010
Last updated: April 8, 2014
Last verified: April 2014

March 12, 2010
April 8, 2014
June 2009
December 2014   (final data collection date for primary outcome measure)
Adverse event profile during long term therapy with piribedil in patients with Parkinson's disease [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01519856 on ClinicalTrials.gov Archive Site
  • Influence on quality of life [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Quality of life parameters [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Change of cognitive function [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Quality of life parameters [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
PIRLONG-PD Safety and Efficacy of Piribedil in Parkinson's Disease During Long Term Therapy
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

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

male and female patients with Morbus Parkinson

Parkinson's Disease
Drug: piribedil (Clarium)
oral tablets, 50 mg
tablet
Intervention: Drug: piribedil (Clarium)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
908
February 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01519856
PIR-008/K
No
Desitin Arzneimittel GmbH
Desitin Arzneimittel GmbH
Not Provided
Not Provided
Desitin Arzneimittel GmbH
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP