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

This study has been completed.
Information provided by:
Desitin Arzneimittel GmbH Identifier:
First received: July 28, 2008
Last updated: March 30, 2010
Last verified: July 2008
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 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 Parkinson Clinic Ambulances and Larger Private Practices.

Resource links provided by NLM:

Further study details as provided by Desitin Arzneimittel GmbH:

Primary Outcome Measures:
  • to monitor use in real practice including adverse events on piribedil [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Efficacy [ Time Frame: 3 months ]

Enrollment: 250
Study Start Date: January 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)

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) and/or in combination with other antiparkinsonian drugs.

Exclusion Criteria:

  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Responsible Party: Dr. Martina Wangemann, Desitin Arzneimittel GmbH Identifier: NCT00725478     History of Changes
Other Study ID Numbers: PIR-001/K
Study First Received: July 28, 2008
Last Updated: March 30, 2010

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 Agents
Dopamine Agonists
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antiparkinson Agents
Anti-Dyskinesia Agents processed this record on September 20, 2017