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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02236728
Enrollment
497
Registered
2014-09-11
Start date
2008-02-29
Completion date
Unknown
Last updated
2014-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

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

Interventions

DRUGPramipexole

Sponsors

Boehringer Ingelheim
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Assessment of Patient's demographic characteristics9 months
Assessment of Parkinson's disease characteristics9 months

Secondary

MeasureTime frameDescription
Description of the actual treatments of PD9 months
Evaluation for reasons for choosing pramipexole as treatment9 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)
Evaluation of the state of health perceived by the patient using the questionnaire EQ-5D9 months
Number of patients with adverse events9 months
Assessment of Treatment history9 months3 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
Assessment of Disease Stage Stage according to Hoehn and Yahr and Unified Parkinson Disease Rating Scale III (UPDRS III) scores9 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026