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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00725478
First Posted: July 30, 2008
Last Update Posted: March 31, 2010
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 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)
  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) and/or in combination with other antiparkinsonian drugs.

Exclusion Criteria:

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Dr. Martina Wangemann, Desitin Arzneimittel GmbH
ClinicalTrials.gov Identifier: NCT00725478     History of Changes
Other Study ID Numbers: PIR-001/K
First Submitted: July 28, 2008
First Posted: July 30, 2008
Last Update Posted: March 31, 2010
Last Verified: July 2008

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
Dopamine Agents
Piribedil
Dopamine Agonists
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antiparkinson Agents
Anti-Dyskinesia Agents