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

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: Pramipexole

• Registration Number: NCT02236728
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2008-11
• Status Verified: 2014-09
• Study First Submitted: 2014-09-10
• Study First Submitted QC: 2014-09-10
• Last Update Submitted: 2014-09-10
• Study First Posted: 2014-09-11
• Last Update Posted: 2014-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 497

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parkinson's disease patients	Pramipexole	-

Primary Outcome Measures

Name	Time	Method
Assessment of Parkinson's disease characteristics	9 months
Assessment of Patient's demographic characteristics	9 months

Secondary Outcome Measures

Name	Time	Method
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	(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)
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	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