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Tolerability of Sifrol® in Ambulatory Patients Suffering From Parkinson's Disease

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT02248207
Collaborator
(none)
1,293
Enrollment

Study Details

Study Description

Brief Summary

Study to obtain information about the co-operation of the different physician-colleagues in the treatment of patients with Parkinson's disease, both in private practices and clinics and about the primary treatment strategies in the pharmacotherapy of Parkinson's disease and to collect data on the tolerability of Sifrol® in ambulatory patients suffering from Parkinson's disease under routing conditions

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
1293 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Management of Parkinson's Disease Patients at Their First Visits in a Neurological Practice
Study Start Date :
Jan 1, 2003
Actual Primary Completion Date :
Nov 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Parkinson Disease patients

Drug: Pramipexole
Other Names:
  • Sifrol®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Global Assessment of efficacy by investigator on a 4-point scale [after 8 weeks]

    2. Change from Baseline in actual Parkinson symptoms [Baseline, after 8 weeks]

    3. Global Assessment of tolerability by investigator on a 4-point scale [after 8 weeks]

    Secondary Outcome Measures

    1. Number of patients with adverse drug reactions [up to 8 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with Parkinson's disease who present to the specialist neurologist practice for the first time without or with referral and who are planned to receive or either be switched to Sifrol or continue the previously prescribed therapy with Sifrol® can be included in this observational study
    Exclusion Criteria:
    • Neurologists are asked to consider the Summary of Product Characteristics (SPC) for Sifrol®

    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:
    NCT02248207
    Other Study ID Numbers:
    • 248.527
    First Posted:
    Sep 25, 2014
    Last Update Posted:
    Sep 25, 2014
    Last Verified:
    Sep 1, 2014
    Additional relevant MeSH terms:
    Parkinson Disease
    Pramipexole

    Study Results

    No Results Posted as of Sep 25, 2014