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SEDPARK1: Safety and Efficacy Study With the Non-ergot Dopamine-agonist Piribedil in Parkinson's Disease (PIR-001/K)

This study has been completed.
Sponsor:
Information provided by:
Desitin Arzneimittel GmbH
ClinicalTrials.gov Identifier:
NCT00725478
First received: July 28, 2008
Last updated: March 30, 2010
Last verified: July 2008
History of Changes
  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

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 Parkinson Clinic Ambulances and Larger 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 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 ]

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

Publications:

Responsible Party: Dr. Martina Wangemann, Desitin Arzneimittel GmbH
ClinicalTrials.gov Identifier: NCT00725478     History of Changes
Other Study ID Numbers: PIR-001/K
Study First Received: July 28, 2008
Last Updated: March 30, 2010
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
Dopamine
Dopamine Agents
Piribedil
Dopamine Agonists
Cardiotonic Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013