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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Desitin Arzneimittel GmbH
ClinicalTrials.gov Identifier:
NCT01519856
First received: March 12, 2010
Last updated: April 8, 2014
Last verified: April 2014
  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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Influence on quality of life [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Quality of life parameters [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Enrollment: 908
Study Start Date: June 2009
Estimated Study Completion Date: February 2015
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519856

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

Additional Information:
Publications:
Responsible Party: Desitin Arzneimittel GmbH
ClinicalTrials.gov Identifier: NCT01519856     History of Changes
Other Study ID Numbers: PIR-008/K
Study First Received: March 12, 2010
Last Updated: April 8, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Piribedil
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014