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

September 22, 2014 updated by: Boehringer Ingelheim

Mirapex PMS Study Final Report

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1449

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with idiopathic Parkinson's disease

Description

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.

    1. Patients who are hypersensitive to MIRAPEX or its ingredients
    2. Refer to the insert paper for other contraindication.
  • Following patients should be carefully administered.

    1. Patient with renal impairment
    2. Refer to the insert paper for other precaution.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Idiopathic Parkinson's disease patients
Other Names:
  • Mirapex®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Unified Parkinson's disease Rating Scale (UPDRS)
Time Frame: up to 4 weeks
Tremor at rest, Rigidity, Body bradykinesia and hypokinesia
up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with adverse events
Time Frame: up to 4 weeks
up to 4 weeks
Global Assessment of efficacy by investigator on 3-point scale
Time Frame: after 4 weeks
after 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

September 22, 2014

First Submitted That Met QC Criteria

September 22, 2014

First Posted (Estimate)

September 25, 2014

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 22, 2014

Last Verified

September 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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