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

Sponsored by:	Desitin Arzneimittel GmbH
Information provided by:	Desitin Arzneimittel GmbH
ClinicalTrials.gov Identifier:	NCT00725478

Purpose

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.

Condition	Intervention
Parkinson's Disease	Drug: Piribedil

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Dopamine Dopamine hydrochloride Loratadine Piribedil

U.S. FDA Resources

Study Type:	Observational
Study Design:	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 Parkinson Clinic Ambulances and Larger Private Practices.

Further study details as provided by Desitin Arzneimittel GmbH:

Primary Outcome Measures:

to monitor use in real practice including adverse events on piribedil [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Efficacy [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	250
Study Start Date:	January 2008
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with Morbus Parkinson who require therapy with dopamine agonists.

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:

Contacts and Locations

No Contacts or Locations Provided

More Information

Piribedil in Parkinson's disease This link exits the ClinicalTrials.gov site

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.

Responsible Party:	Desitin Arzneimittel GmbH ( Dr. Martina Wangemann )
Study ID Numbers:	PIR-001/K
Study First Received:	July 28, 2008
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00725478
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Desitin Arzneimittel GmbH:

Piribedil (trade name: CLARIUM)
non-ergot dopamine agonist
Morbus Parkinson
Tolerability

Efficacy
Post Marketing Surveillance
Morbus Parkinson

Study placed in the following topic categories:

Dopamine
Ganglion Cysts
Loratadine
Piribedil
Movement Disorders
Parkinson Disease

Basal Ganglia Diseases
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Cardiotonic Agents
Sympathomimetics
Nervous System Diseases
Physiological Effects of Drugs
Antiparkinson Agents
Cardiovascular Agents

Dopamine Agonists
Protective Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009