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OpenTrials
Completed

NCT Number: NCT02248168

Post Marketing Surveillance And Special Surveillance for Mirapex® Tablet in Patients With Idiopathic Parkinson's Disease

The objectives of this study are to investigate issues or questions about MIRAPEX Tablets as shown below through the Post Marketing Surveillance (PMS) study upon approval.

* Unexpected adverse events (especially, serious adverse events (SAEs)) * To find out the status of incidence of adverse events under actual practice * Factors on the safety profile * Factors on the efficacy profile

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Among the patients with idiopathic Parkinson's disease, from those receiving MIRAPEX Tablets first after a contract of the study to the requested number of cases will be consecutively enrolled without skipping

Exclusion criteria

  • Following patients are contraindicated.
  • Patients who are hypersensitive to MIRAPEX or its ingredients
  • Refer to the insert paper for other contraindication.
  • Following patients should be carefully administered.
  • Patient with renal impairment
  • Refer to the insert paper for other precaution.

Treatment and study plan

Pramipexole

Drug

Other names: Mirapex®

Primary outcomes

  1. Assessment of Unified Parkinson's disease Rating Scale (UPDRS)

    Time frame: up to 4 weeks

    Tremor at rest, Rigidity, Body bradykinesia and hypokinesia

Secondary outcomes

  1. Number of patients with adverse events

    Time frame: up to 4 weeks

  2. Global Assessment of efficacy by investigator on 3-point scale

    Time frame: after 4 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Mirapex PMS Study Final Report

Important dates

Study start
2002
Primary completion
2007
First posted
Sep 25, 2014
Registry last updated
Sep 25, 2014

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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