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SEDPARK2: Post Marketing Surveillance to Observe Safety and Efficacy of Piribedil in Parkinson's Disease (PIR-002/K)

This study has been completed.
Sponsor:
Information provided by:
Desitin Arzneimittel GmbH
ClinicalTrials.gov Identifier:
NCT00727727
First received: July 31, 2008
Last updated: February 24, 2009
Last verified: February 2009
History of Changes
  Purpose

The objective of the Post Marketing Surveillance 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. Neurologists in private practices in Germany should document the safety and course of the disease/change of parkinsonian symptoms during stabilisation on, or change over from other dopamine agonist treatment under routine conditions. Piribedil should be prescribed according to its marketing authorisation.


Condition Intervention
Parkinson's Disease
 Drug: Piribedil

Study Type: Observational
Study Design: Time Perspective: 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 Private Practices.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Desitin Arzneimittel GmbH:

Primary Outcome Measures:
  • to monitor use in daily routine practice including adverse events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • to monitor use in daily routine practice including efficacy aspects [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 750
Study Start Date: March 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Parkinsonian patients Drug: Piribedil

  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 in combination with other antiparkinsonian drugs).

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727727

Locations
Germany
Medical Practice for Neurology
Dresden, Germany, 01307
Medical Practice for Neurology
Wedel, Germany, 22880
Sponsors and Collaborators
Desitin Arzneimittel GmbH
  More Information

Publications:

Responsible Party: Dr. Martina Wangemann, Desitin Arzneimittel GmbH
ClinicalTrials.gov Identifier: NCT00727727     History of Changes
Other Study ID Numbers: PIR-002/K
Study First Received: July 31, 2008
Last Updated: February 24, 2009
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

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
Dopamine Agonists
 Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013