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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00725478

Acronym

PIR-001/K

Enrollment

250

Registered

2008-07-30

Start date

2008-01-31

Completion date

2008-06-30

Last updated

2010-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Piribedil (trade name: CLARIUM), non-ergot dopamine agonist, Morbus Parkinson, Tolerability, Efficacy, Post Marketing Surveillance

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.

Interventions

DRUGPiribedil

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
to monitor use in real practice including adverse events on piribedil	3 months

Secondary

Measure	Time frame
Efficacy	3 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026