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

Overview

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

Full Title of Study: “Observational Study in Parkinson’s Disease of the Primary Care Population of Patients Treated With Pramipexole by Neurologists in France (ETAP)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2008

Interventions

  • Drug: Pramipexole

Arms, Groups and Cohorts

  • Parkinson’s disease patients

Clinical Trial Outcome Measures

Primary Measures

  • Assessment of Patient’s demographic characteristics
    • Time Frame: 9 months
  • Assessment of Parkinson’s disease characteristics
    • Time Frame: 9 months

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Boehringer Ingelheim
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.