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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT02236728
Collaborator
(none)
497
Enrollment

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
497 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Observational Study in Parkinson's Disease of the Primary Care Population of Patients Treated With Pramipexole by Neurologists in France (ETAP)
Study Start Date :
Feb 1, 2008
Actual Primary Completion Date :
Nov 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Parkinson's disease patients

Drug: Pramipexole
Other Names:
  • (Sifrol®)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Assessment of Patient's demographic characteristics [9 months]

    2. Assessment of Parkinson's disease characteristics [9 months]

    Secondary Outcome Measures

    1. 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)

    2. Assessment of Disease Stage Stage according to Hoehn and Yahr and Unified Parkinson Disease Rating Scale III (UPDRS III) scores [9 months]

    3. Description of the actual treatments of PD [9 months]

    4. Evaluation for reasons for choosing pramipexole as treatment [9 months]

    5. 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

    6. Evaluation of the state of health perceived by the patient using the questionnaire EQ-5D [9 months]

    7. Number of patients with adverse events [9 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Boehringer Ingelheim

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Boehringer Ingelheim
    ClinicalTrials.gov Identifier:
    NCT02236728
    Other Study ID Numbers:
    • 248.648
    First Posted:
    Sep 11, 2014
    Last Update Posted:
    Sep 11, 2014
    Last Verified:
    Sep 1, 2014
    Additional relevant MeSH terms:
    Parkinson Disease
    Pramipexole

    Study Results

    No Results Posted as of Sep 11, 2014