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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00727727
First Posted: August 4, 2008
Last Update Posted: February 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Desitin Arzneimittel GmbH
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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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
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00727727


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

Publications:
Responsible Party: Dr. Martina Wangemann, Desitin Arzneimittel GmbH
ClinicalTrials.gov Identifier: NCT00727727     History of Changes
Other Study ID Numbers: PIR-002/K
First Submitted: July 31, 2008
First Posted: August 4, 2008
Last Update Posted: February 25, 2009
Last Verified: February 2009

Keywords provided by Desitin Arzneimittel GmbH:
Piribedil (trade name: Clarium)
non-ergot dopamine agonist
Morbus Parkinson
Tolerability
Efficacy
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
Piribedil
Dopamine Agonists
Cardiotonic Agents
Sympathomimetics
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