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

NCT00727727 | Completed

• 1 other identifier: PIR-002/K
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson's Disease

Keywords

Piribedil (trade name: Clarium); non-ergot dopamine agonist; Morbus Parkinson; Tolerability; Efficacy; Post Marketing Surveillance

Outcome Measures

Primary Outcomes (1)

• to monitor use in daily routine practice including adverse events

  3 months

Secondary Outcomes (1)

• to monitor use in daily routine practice including efficacy aspects

  3 months

Study Arms (1)

Parkinsonian patients

Drug: Piribedil

Interventions

Piribedil DRUG

Parkinsonian patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Morbus Parkinson who require therapy with dopamine agonists

You may qualify if:

• 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).

Sponsors & Collaborators

• Desitin Arzneimittel GmbH: lead

Study Sites (2)

Medical Practice for Neurology

Dresden, 01307, Germany

Location

Medical Practice for Neurology

Wedel, 22880, Germany

Location

Related 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. doi: 10.1002/mds.20750.

  PMID: 16267842 BACKGROUND

• 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. doi: 10.1002/mds.21122.

  PMID: 17013922 BACKGROUND

• Rascol O, Pathak A, Bagheri H, Montastruc JL. Dopaminagonists and fibrotic valvular heart disease: further considerations. Mov Disord. 2004 Dec;19(12):1524-5. doi: 10.1002/mds.20328. No abstract available.

  PMID: 15515031 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Piribedil

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 31, 2008
• First Posted: August 4, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 25, 2009

Record last verified: 2009-02

Locations

DE (2)