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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00727727

Enrollment

750

Registered

2008-08-04

Start date

2008-03-31

Completion date

2008-12-31

Last updated

2009-02-25

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 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.

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 in combination with other antiparkinsonian drugs).

Design outcomes

Primary

Measure	Time frame
to monitor use in daily routine practice including adverse events	3 months

Secondary

Measure	Time frame
to monitor use in daily routine practice including efficacy aspects	3 months

Countries

Germany

Outcome results

None listed

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