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:
Information provided by:
Desitin Arzneimittel GmbH
ClinicalTrials.gov Identifier:
NCT00725478
First received: July 28, 2008
Last updated: March 30, 2010
Last verified: July 2008

July 28, 2008
March 30, 2010
January 2008
June 2008   (final data collection date for primary outcome measure)
to monitor use in real practice including adverse events on piribedil [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00725478 on ClinicalTrials.gov Archive Site
Efficacy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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SEDPARK1: Safety and Efficacy Study With the Non-ergot Dopamine-agonist Piribedil in Parkinson's Disease
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.

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.

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Observational
Time Perspective: Prospective
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Non-Probability Sample

Patients with Morbus Parkinson who require therapy with dopamine agonists.

Parkinson's Disease
Drug: Piribedil
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
June 2008
June 2008   (final data collection date for primary outcome measure)

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:

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00725478
PIR-001/K
No
Dr. Martina Wangemann, Desitin Arzneimittel GmbH
Desitin Arzneimittel GmbH
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Desitin Arzneimittel GmbH
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP