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

Parkinson's Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00727727
• Other study ID #: PIR-002/K
• Status: Completed
• Phase: N/A
• First received: July 31, 2008
• Last updated: February 24, 2009
• Start date: March 2008
• Est. completion date: December 2008

Study information

• Verified date: February 2009
• Source: Desitin Arzneimittel GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Piribedil

Locations

Country	Name	City	State
Germany	Medical Practice for Neurology	Dresden
Germany	Medical Practice for Neurology	Wedel

Sponsors (1)

Lead Sponsor	Collaborator
Desitin Arzneimittel GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View Citation

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. — View Citation

Rascol O, Pathak A, Bagheri H, Montastruc JL. Dopaminagonists and fibrotic valvular heart disease: further considerations. Mov Disord. 2004 Dec;19(12):1524-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to monitor use in daily routine practice including adverse events		3 months	Yes
Secondary	to monitor use in daily routine practice including efficacy aspects		3 months	No