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Post Marketing Surveillance And Special Surveillance for Mirapex® Tablet in Patients With Idiopathic Parkinson's Disease

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT02248168
Collaborator
(none)
1,449
Enrollment

Study Details

Study Description

Brief Summary

The objectives of this study are to investigate issues or questions about MIRAPEX Tablets as shown below through the Post Marketing Surveillance (PMS) study upon approval.

  • Unexpected adverse events (especially, serious adverse events (SAEs))

  • To find out the status of incidence of adverse events under actual practice

  • Factors on the safety profile

  • Factors on the efficacy profile

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
1449 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Mirapex PMS Study Final Report
Study Start Date :
Mar 1, 2002
Actual Primary Completion Date :
Jan 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Idiopathic Parkinson's disease patients

Drug: Pramipexole
Other Names:
  • Mirapex®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Assessment of Unified Parkinson's disease Rating Scale (UPDRS) [up to 4 weeks]

      Tremor at rest, Rigidity, Body bradykinesia and hypokinesia

    Secondary Outcome Measures

    1. Number of patients with adverse events [up to 4 weeks]

    2. Global Assessment of efficacy by investigator on 3-point scale [after 4 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Among the patients with idiopathic Parkinson's disease, from those receiving MIRAPEX Tablets first after a contract of the study to the requested number of cases will be consecutively enrolled without skipping
    Exclusion Criteria:
    • Following patients are contraindicated.

    1. Patients who are hypersensitive to MIRAPEX or its ingredients

    2. Refer to the insert paper for other contraindication.

    • Following patients should be carefully administered.

    1. Patient with renal impairment

    2. Refer to the insert paper for other precaution.

    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:
    NCT02248168
    Other Study ID Numbers:
    • 248.599
    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