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

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ClinicalTrials.gov Identifier: NCT00725478
Recruitment Status : Completed
First Posted : July 30, 2008
Last Update Posted : March 31, 2010
Sponsor:
Information provided by:
Desitin Arzneimittel GmbH

Brief Summary:
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 or disease Intervention/treatment
Parkinson's Disease Drug: Piribedil

Study Type : Observational
Actual Enrollment : 250 participants
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.
Study Start Date : January 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Dopamine




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

Secondary Outcome Measures :
  1. Efficacy [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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:


Publications:
Responsible Party: Dr. Martina Wangemann, Desitin Arzneimittel GmbH
ClinicalTrials.gov Identifier: NCT00725478     History of Changes
Other Study ID Numbers: PIR-001/K
First Posted: July 30, 2008    Key Record Dates
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