PIR-001/K: SEDPARK1: Safety and Efficacy Study With the Non-ergot Dopamine-agonist Piribedil in Parkinson's Disease

Sponsor

Desitin Arzneimittel GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT00725478

Collaborator

(none)

250

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

The aim of the non-interventional Post Marketing 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. Tolerability and course of the disease or change of parkinsonian symptoms during stabilisation on, or change over from other dopamine agonists will be documented under routine conditions. Piribedil should be prescribed according to its marketing authorisation by the responsible neurologist.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: Piribedil

Study Design

Study Type:

Observational

Actual Enrollment :

250 participants

Time Perspective:

Prospective

Official Title:

Stabilization on, or Change-over to the Non-ergot Dopamine Agonist Piribedil in Patients With Morbus Parkinson - a Post Marketing Surveillance Study in Parkinson Clinic Ambulances and Larger Private Practices.

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Jun 1, 2008

Outcome Measures

Primary Outcome Measures

to monitor use in real practice including adverse events on piribedil [3 months]

Secondary Outcome Measures

Efficacy [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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) and/or in combination with other antiparkinsonian drugs.