SEDPARK2: Post Marketing Surveillance to Observe Safety and Efficacy of Piribedil in Parkinson's Disease (PIR-002/K)

February 24, 2009 updated by: Desitin Arzneimittel GmbH

Stabilization on, or Change-Over to the Non-Ergot Dopamine Agonist Piribedil in Patients With Morbus Parkinson - a Post Marketing Surveillance Study in Private Practices.

The objective of the Post Marketing Surveillance Study is to investigate the use of the non-ergot dopamine agonist piribedil (trade name: CLARIUM) in mono- and combination therapy in patients with Morbus Parkinson. Neurologists in private practices in Germany should document the safety and course of the disease/change of parkinsonian symptoms during stabilisation on, or change over from other dopamine agonist treatment under routine conditions. Piribedil should be prescribed according to its marketing authorisation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

750

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
      • Dresden, Germany, 01307
        • Medical Practice for Neurology
      • Wedel, Germany, 22880
        • Medical Practice for Neurology

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Morbus Parkinson who require therapy with dopamine agonists

Description

Inclusion Criteria:

  • Male and female patients 18 years and older.
  • Indication: Morbus Parkinson.
  • Treatment with piribedil for the first time.
  • Monotherapy with piribedil.
  • Combination therapy with L-Dopa (from the beginning or secondary in combination with other antiparkinsonian drugs).

Exclusion Criteria:

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
Parkinsonian patients
Drug: Piribedil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
to monitor use in daily routine practice including adverse events
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
to monitor use in daily routine practice including efficacy aspects
Time Frame: 3 months
3 months

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

March 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

July 31, 2008

First Submitted That Met QC Criteria

August 1, 2008

First Posted (Estimate)

August 4, 2008

Study Record Updates

Last Update Posted (Estimate)

February 25, 2009

Last Update Submitted That Met QC Criteria

February 24, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIR-002/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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