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

Desitin

Status: Completed

Conditions: Parkinson's Disease

Treatments: Drug: Piribedil

Study type: Observational

Funder types: Industry

Identifiers

NCT00727727

PIR-002/K

Details and patient eligibility

About

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.

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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:

Trial design

750 participants in 1 patient group

Parkinsonian patients

Treatment:

Drug: Piribedil