SEDPARK1: Safety and Efficacy Study With the Non-ergot Dopamine-agonist Piribedil in Parkinson's Disease

NCT00725478 | Completed

• 1 other identifier: PIR-001/K
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

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 real practice including adverse events on piribedil

  3 months

Secondary Outcomes (1)

• Efficacy

  3 months

Interventions

Piribedil DRUG

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) and/or in combination with other antiparkinsonian drugs.

Sponsors & Collaborators

• Desitin Arzneimittel GmbH: lead

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 28, 2008
• First Posted: July 30, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: March 31, 2010

Record last verified: 2008-07