Observational Study in Parkinson's Disease of the Primary Care Population of Patients Treated With Pramipexole

September 10, 2014 updated by: Boehringer Ingelheim

Observational Study in Parkinson's Disease of the Primary Care Population of Patients Treated With Pramipexole by Neurologists in France (ETAP)

The primary objective of this study was to describe neurologists' population of patients treated with pramipexole and suffering from Parkinson's disease (so called 'primary care' population).

The secondary objectives were:

  • Evaluate the mean dose of pramipexole prescribed under actual conditions of use depending on the severity of the disease.
  • Evaluate the reasons for choosing pramipexole as treatment.
  • Identify the patient profiles determining the choice of dose of pramipexole prescribed

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

497

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

neurologists' population of patients treated with pramipexole and suffering from Parkinson's disease (so called 'primary care' population)

Description

Inclusion Criteria:

  • Patients suffering from idiopathic Parkinson's Disease and treated with pramipexole for at least two months, examined in consultation

Exclusion Criteria:

  • Patient refusing to take part
  • Patient taking part in a clinical trial

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's disease patients
Drug: Pramipexole
Other Names:
  • (Sifrol®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of Patient's demographic characteristics
Time Frame: 9 months
9 months
Assessment of Parkinson's disease characteristics
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Severity of the Parkinson Disease (PD)
Time Frame: 9 months
(levels of severity of the disease were defined with the scientific committee in 5 stages: treatment initiation phase, honeymoon phase, therapeutic insufficiency phase, start of motor complications phase and advanced motor complications phase)
9 months
Assessment of Disease Stage Stage according to Hoehn and Yahr and Unified Parkinson Disease Rating Scale III (UPDRS III) scores
Time Frame: 9 months
9 months
Description of the actual treatments of PD
Time Frame: 9 months
9 months
Evaluation for reasons for choosing pramipexole as treatment
Time Frame: 9 months
9 months
Assessment of Treatment history
Time Frame: 9 months
3 subgroups: Initiation: no antiparkinson treatment before the implementation of pramipexole Switch: at least one dopamine agonist replaced by pramipexole Add on: pramipexole is implemented in addition to the previous treatment
9 months
Evaluation of the state of health perceived by the patient using the questionnaire EQ-5D
Time Frame: 9 months
9 months
Number of patients with adverse events
Time Frame: 9 months
9 months

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, 2008

Primary Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

September 10, 2014

First Submitted That Met QC Criteria

September 10, 2014

First Posted (Estimate)

September 11, 2014

Study Record Updates

Last Update Posted (Estimate)

September 11, 2014

Last Update Submitted That Met QC Criteria

September 10, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 248.648

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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