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PIRLONG-PD Safety and Efficacy of Piribedil in Parkinson's Disease During Long Term Therapy (PIR-008/K)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01519856
First Posted: January 27, 2012
Last Update Posted: January 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Desitin Arzneimittel GmbH
  Purpose
Non-Ergot Dopamine agonists are meanwhile the drugs of first-choice in the treatment of Parkinson's disease. The receptor profile of the non-ergot dopamine-agonist piribedil is unique. In addition to agonistic effects on dopaminergic D2- and D3-receptors piribedil has adrenergic alpha-2A- and alpha-2C-receptors antagonisic properties. There is evidence from the literature that the antagonistic properties of piribedil are correlated with an improvement of cognitive function and vigilance parameters in parkinson's disease. The aim of the present non-interventional study is to investigate the safety and efficacy of piribedil during long-term therapy of patients with M. Parkinson under consideration of cognitive functions and quality of life.

Condition Intervention
Parkinson's Disease Drug: piribedil (Clarium)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Efficacy and Safety of Long-term Therapy With Piribedil (CLARIUM) in Patients With M. Parkinson Under Consideration of Quality of Life Parameters and Cognitive Function

Resource links provided by NLM:


Further study details as provided by Desitin Arzneimittel GmbH:

Primary Outcome Measures:
  • Adverse event profile during long term therapy with piribedil in patients with Parkinson's disease [ Time Frame: 4 years ]

Secondary Outcome Measures:
  • Influence on quality of life [ Time Frame: 4 years ]
  • Quality of life parameters [ Time Frame: 4 years ]

Enrollment: 908
Study Start Date: June 2009
Study Completion Date: February 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
tablet Drug: piribedil (Clarium)
oral tablets, 50 mg

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
male and female patients with Morbus Parkinson
Criteria

Inclusion Criteria:

  • newly diagnosed or advanced idiopathic Parkinson's disease
  • male and female patients over 18 years of age
  • indication for treatment with piribedil according to Summary of Product Characteristics (SmPC)

Exclusion Criteria:

  • in line with piribedil SmPC
  • in particular hypersensitivity to piribedil or to any of the excipients and pregnancy and lactation as stated in the SmPC
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01519856


Locations
Germany
Dr. Erich Scholz
Boeblingen, Baden-Wuertemberg, Germany, 71034
Sponsors and Collaborators
Desitin Arzneimittel GmbH
  More Information

Publications:
Responsible Party: Desitin Arzneimittel GmbH
ClinicalTrials.gov Identifier: NCT01519856     History of Changes
Other Study ID Numbers: PIR-008/K
First Submitted: March 12, 2010
First Posted: January 27, 2012
Last Update Posted: January 29, 2016
Last Verified: July 2015

Keywords provided by Desitin Arzneimittel GmbH:
open
non-intervention
observational

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Piribedil
Loratadine
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipruritics
Dermatologic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents