SEDPARK1: Safety and Efficacy Study With the Non-Ergot Dopamine-Agonist Piribedil in Parkinson's Disease - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information
First Received Date ^†	July 28, 2008
Last Updated Date	August 7, 2008
Start Date ^†	January 2008
Current Primary Outcome Measures ^† (submitted: July 31, 2008)	to monitor use in real practice including adverse events on piribedil [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^†	Same as current
Change History	Complete list of historical versions of study NCT00725478 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^† (submitted: July 31, 2008)	Efficacy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^†	Same as current

Descriptive Information
Brief Title ^†	SEDPARK1: Safety and Efficacy Study With the Non-Ergot Dopamine-Agonist Piribedil in Parkinson's Disease
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.
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.
Detailed Description
Study Phase
Study Type ^†	Observational
Study Design ^†	Other, Prospective
Condition ^†	Parkinson's Disease
Intervention ^†	Drug: Piribedil
Study Arms / Comparison Groups
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 National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^†	Completed
Enrollment ^†	250
Completion Date	June 2008
Primary Completion Date	June 2008 (final data collection date for primary outcome measure)
Eligibility 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:
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†
Expanded Access Status

Administrative Information
NCT ID ^†	NCT00725478
Responsible Party	Dr. Martina Wangemann, Desitin Arzneimittel GmbH
Secondary IDs ^††
Study Sponsor ^†	Desitin Arzneimittel GmbH
Collaborators ^††
Investigators ^†
Information Provided By	Desitin Arzneimittel GmbH
Verification Date	July 2008
^† Required WHO trial registration data element. ^†† WHO trial registration data element that is required only if it exists.