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Completed

NCT Number: NCT01519856

PIRLONG-PD Safety and Efficacy of Piribedil in Parkinson's Disease During Long Term Therapy

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Erich Scholz

Böblingen, Baden-Wurttemberg, 71034, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

piribedil (Clarium)

Drug

oral tablets, 50 mg

Primary outcomes

  1. Adverse event profile during long term therapy with piribedil in patients with Parkinson's disease

    Time frame: 4 years

Secondary outcomes

  1. Influence on quality of life

    Time frame: 4 years

  2. Quality of life parameters

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

Desitin Arzneimittel GmbH

Industry

Registry information

Official study 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

Acronym: PIR-008/K

Important dates

Study start
2009
Primary completion
2014
Study completion
2015
First posted
Jan 27, 2012
Registry last updated
Jan 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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