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

This study has been completed.
Information provided by:
Desitin Arzneimittel GmbH Identifier:
First received: July 31, 2008
Last updated: February 24, 2009
Last verified: February 2009
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.

Condition Intervention
Parkinson's Disease Drug: Piribedil

Study Type: Observational
Study Design: 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 Private Practices.

Resource links provided by NLM:

Further study details as provided by Desitin Arzneimittel GmbH:

Primary Outcome Measures:
  • to monitor use in daily routine practice including adverse events [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • to monitor use in daily routine practice including efficacy aspects [ Time Frame: 3 months ]

Estimated Enrollment: 750
Study Start Date: March 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Parkinsonian patients Drug: Piribedil


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Morbus Parkinson who require therapy with dopamine agonists

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:

  Contacts and Locations
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Please refer to this study by its identifier: NCT00727727

Medical Practice for Neurology
Dresden, Germany, 01307
Medical Practice for Neurology
Wedel, Germany, 22880
Sponsors and Collaborators
Desitin Arzneimittel GmbH
  More Information

Responsible Party: Dr. Martina Wangemann, Desitin Arzneimittel GmbH Identifier: NCT00727727     History of Changes
Other Study ID Numbers: PIR-002/K
Study First Received: July 31, 2008
Last Updated: February 24, 2009

Keywords provided by Desitin Arzneimittel GmbH:
Piribedil (trade name: Clarium)
non-ergot dopamine agonist
Morbus Parkinson
Post Marketing Surveillance

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dopamine Agonists
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antiparkinson Agents
Anti-Dyskinesia Agents processed this record on September 21, 2017