Tolerability of Sifrol® in Ambulatory Patients Suffering From Parkinson's Disease

September 22, 2014 updated by: Boehringer Ingelheim

Management of Parkinson's Disease Patients at Their First Visits in a Neurological Practice

Study to obtain information about the co-operation of the different physician-colleagues in the treatment of patients with Parkinson's disease, both in private practices and clinics and about the primary treatment strategies in the pharmacotherapy of Parkinson's disease and to collect data on the tolerability of Sifrol® in ambulatory patients suffering from Parkinson's disease under routing conditions

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1293

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 Parkinson's disease recruited at specialist neurologist (private practices and clinics)

Description

Inclusion Criteria:

  • Patients with Parkinson's disease who present to the specialist neurologist practice for the first time without or with referral and who are planned to receive or either be switched to Sifrol or continue the previously prescribed therapy with Sifrol® can be included in this observational study

Exclusion Criteria:

  • Neurologists 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
Parkinson Disease patients
Drug: Pramipexole
Other Names:
  • Sifrol®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Global Assessment of efficacy by investigator on a 4-point scale
Time Frame: after 8 weeks
after 8 weeks
Change from Baseline in actual Parkinson symptoms
Time Frame: Baseline, after 8 weeks
Baseline, after 8 weeks
Global Assessment of tolerability by investigator on a 4-point 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

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

January 1, 2003

Primary Completion (Actual)

November 1, 2003

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

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 248.527

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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