Post Marketing Surveillance Study in Patients With Idiopathic Parkinson's Disease

September 16, 2014 updated by: Boehringer Ingelheim

Switch Post Marketing Surveillance Study in Patients With Idiopathic Parkinson's Disease

Documentation of the effect of an direct or overlapping switch from another dopamine agonist to Sifrol® on motor function, psychopathological disturbances and mood, assessment of the reasons for the switch and the reasons for using Sifrol®, equivalent doses at the end of the switch and tolerability of Sifrol® in ambulatory patients suffering from idiopathic Parkinson's disease under routine conditions

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1216

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Idiopathic Parkinson's disease patients recruited at office-based neurologists, psychiatrist or special neurology clinics

Description

Inclusion Criteria:

  • Patients with Idiopathic Parkinson's disease who are planned to undergo a switch from another dopamine agonist to Sifrol®

Exclusion Criteria:

  • Neurologists and psychiatrists are asked to consider the Summary of Product Characteristics (SPC) for Sifrol®

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
Drug: Sifrol®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reason for switch of therapy and reason for using Sifrol®
Time Frame: up to 8 weeks
questionnaire
up to 8 weeks
Type of switch (abrupt or overlapping)
Time Frame: up to 8 weeks
up to 8 weeks
Changes in motor function by means of 5-points rating scale
Time Frame: up to 8 weeks
Short Parkinson's Evaluation Scale (SPES)
up to 8 weeks
Changes in psychopathological memory disturbances by means of 5- point rating scale
Time Frame: up to 8 weeks
Short Parkinson's Evaluation Scale (SPES)
up to 8 weeks
Changes in psychopathological thought disorder disturbances by means of 5- point rating scale
Time Frame: up to 8 weeks
SPES score
up to 8 weeks
Changes in psychopathological depression disturbances by means of 5- point rating scale
Time Frame: up to 8 weeks
SPES score
up to 8 weeks
Changes of mood on seven visual analogue scales (VASs)
Time Frame: up to 8 weeks
assessed by patient
up to 8 weeks
Equivalent doses of Sifrol®
Time Frame: after 8 weeks
compared to previous treatment dosing, based on global clinical impression
after 8 weeks
Global assessment of efficacy by investigator on a 5-point rating scale
Time Frame: after 8 weeks
after 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with adverse drug reactions
Time Frame: up to 8 weeks
up to 8 weeks
Assessment of tolerability by investigator on a 5-point rating scale
Time Frame: after 8 weeks
after 8 weeks

Collaborators and Investigators

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

Sponsor

Boehringer Ingelheim

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

February 1, 2002

Primary Completion (Actual)

December 1, 2002

Study Registration Dates

First Submitted

September 2, 2014

First Submitted That Met QC Criteria

September 2, 2014

First Posted (Estimate)

September 4, 2014

Study Record Updates

Last Update Posted (Estimate)

September 17, 2014

Last Update Submitted That Met QC Criteria

September 16, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 248.517

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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