SEDPARK2: Post Marketing Surveillance to Observe Safety and Efficacy of Piribedil in Parkinson's Disease (PIR-002/K)

This study has been completed.
Sponsor:
Information provided by:
Desitin Arzneimittel GmbH
ClinicalTrials.gov Identifier:
NCT00727727
First received: July 31, 2008
Last updated: February 24, 2009
Last verified: February 2009

July 31, 2008
February 24, 2009
March 2008
December 2008   (final data collection date for primary outcome measure)
to monitor use in daily routine practice including adverse events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
to monitor use in daily routine practice including adverse events [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00727727 on ClinicalTrials.gov Archive Site
to monitor use in daily routine practice including efficacy aspects [ Time Frame: 3 months ] [ Designated as safety issue: No ]
to monitor use in daily routine practice including efficacy aspects [ Designated as safety issue: No ]
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SEDPARK2: Post Marketing Surveillance to Observe Safety and Efficacy of Piribedil in Parkinson's Disease (PIR-002/K)
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.

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.

Not Provided
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
Parkinsonian patients
Intervention: Drug: Piribedil

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
750
December 2008
December 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 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
Germany
 
NCT00727727
PIR-002/K
No
Dr. Martina Wangemann, Desitin Arzneimittel GmbH
Desitin Arzneimittel GmbH
Not Provided
Not Provided
Desitin Arzneimittel GmbH
February 2009

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