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

January 28, 2016 updated by: Desitin Arzneimittel GmbH

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

908

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Wuertemberg
      • Boeblingen, Baden-Wuertemberg, Germany, 71034
        • Dr. Erich Scholz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

male and female patients with Morbus Parkinson

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
tablet
Drug: piribedil (Clarium)
oral tablets, 50 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse event profile during long term therapy with piribedil in patients with Parkinson's disease
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Influence on quality of life
Time Frame: 4 years
4 years
Quality of life parameters
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Desitin Arzneimittel GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

March 12, 2010

First Submitted That Met QC Criteria

January 26, 2012

First Posted (Estimate)

January 27, 2012

Study Record Updates

Last Update Posted (Estimate)

January 29, 2016

Last Update Submitted That Met QC Criteria

January 28, 2016

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIR-008/K

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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