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

History of Changes

Tracking Information
First Received Date ^ICMJE	July 31, 2008
Last Updated Date	February 24, 2009
Start Date ^ICMJE	March 2008
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 7, 2008)	to monitor use in daily routine practice including adverse events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: August 1, 2008)	to monitor use in daily routine practice including adverse events [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT00727727 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 7, 2008)	to monitor use in daily routine practice including efficacy aspects [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: August 1, 2008)	to monitor use in daily routine practice including efficacy aspects [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	SEDPARK2: Post Marketing Surveillance to Observe Safety and Efficacy of Piribedil in Parkinson's Disease (PIR-002/K)
Official Title ^ICMJE	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.
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients with Morbus Parkinson who require therapy with dopamine agonists
Condition ^ICMJE	Parkinson's Disease
Intervention ^ICMJE	Drug: Piribedil
Study Group/Cohort (s)	Parkinsonian patients Intervention: Drug: Piribedil
Publications *	Castro-Caldas A, Delwaide P, Jost W, Merello M, Williams A, Lamberti P, Aguilar M, Del Signore S, Cesaro P; Parkinson-Control Study Group. The Parkinson-Control study: a 1-year randomized, double-blind trial comparing piribedil (150 mg/day) with bromocriptine (25 mg/day) in early combination with levodopa in Parkinson's disease. Mov Disord. 2006 Apr;21(4):500-9. Rascol O, Dubois B, Caldas AC, Senn S, Del Signore S, Lees A; Parkinson REGAIN Study Group. Early piribedil monotherapy of Parkinson's disease: A planned seven-month report of the REGAIN study. Mov Disord. 2006 Dec;21(12):2110-5. Rascol O, Pathak A, Bagheri H, Montastruc JL. Dopaminagonists and fibrotic valvular heart disease: further considerations. Mov Disord. 2004 Dec;19(12):1524-5. No abstract available.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	750
Completion Date	December 2008
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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:
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT00727727
Other Study ID Numbers ^ICMJE	PIR-002/K
Has Data Monitoring Committee	No
Responsible Party	Dr. Martina Wangemann, Desitin Arzneimittel GmbH
Study Sponsor ^ICMJE	Desitin Arzneimittel GmbH
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Desitin Arzneimittel GmbH
Verification Date	February 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top