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

• Sponsor: Desitin Arzneimittel GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00727727
• Collaborator: (none)
• Enrollment: 750
• Locations: 2
• Duration (Months): 9
• Patients Per Site: 375
• Patients Per Site Per Month: 41.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: Piribedil

Study Design

• Study Type: Observational
• Anticipated Enrollment: 750 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 Private Practices.
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Parkinsonian patients	Drug: Piribedil

Outcome Measures

Primary Outcome Measures

1. to monitor use in daily routine practice including adverse events [3 months]

Secondary Outcome Measures

1. to monitor use in daily routine practice including efficacy aspects [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Practice for Neurology	Dresden		Germany	01307
2	Medical Practice for Neurology	Wedel		Germany	22880

Sponsors and Collaborators

• Desitin Arzneimittel GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

• ClinicalTrials.gov Identifier: NCT00727727
• Other Study ID Numbers: PIR-002/K
• First Posted: Aug 4, 2008
• Last Update Posted: Feb 25, 2009
• Last Verified: Feb 1, 2009

• Keywords provided by , ,: Piribedil (trade name: Clarium); non-ergot dopamine agonist; Morbus Parkinson; Tolerability; Efficacy; Post Marketing Surveillance
• Additional relevant MeSH terms: Parkinson Disease; Piribedil

Study Results

No Results Posted as of Feb 25, 2009