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

Boehringer Ingelheim0 sites497 target enrollmentFebruary 2008

ConditionsParkinson Disease

InterventionsPramipexole

DrugsPramipexole

Overview

Phase: Not Applicable
Intervention: Pramipexole
Conditions: Parkinson Disease
Sponsor: Boehringer Ingelheim
Enrollment: 497
Primary Endpoint: Assessment of Parkinson's disease characteristics
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

February 2008

End Date

November 2008

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Parkinson's disease patients

Intervention: Pramipexole

Outcomes

Primary Outcomes

Assessment of Parkinson's disease characteristics

Time Frame: 9 months

Assessment of Patient's demographic characteristics

Time Frame: 9 months

Secondary Outcomes

Description of the actual treatments of PD(9 months)
Evaluation for reasons for choosing pramipexole as treatment(9 months)
Assessment of Severity of the Parkinson Disease (PD)(9 months)
Assessment of Disease Stage Stage according to Hoehn and Yahr and Unified Parkinson Disease Rating Scale III (UPDRS III) scores(9 months)
Evaluation of the state of health perceived by the patient using the questionnaire EQ-5D(9 months)
Number of patients with adverse events(9 months)
Assessment of Treatment history(9 months)