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Post Marketing Surveillance Study of Sifrol® in Patients With Idiopathic Parkinson's Disease

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT02248181
Collaborator
(none)
442
Enrollment

Study Details

Study Description

Brief Summary

Study to document pramipexole dosing during monotherapy, occurrence of fluctuations and dyskinesias, dose increases after deterioration of Parkinson's disease (PD) symptoms, assessment of the reasons for add-on treatment with L-Dopa and dosing of pramipexole and L-Dopa when given concomitantly.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
442 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Post Marketing Surveillance Study of Sifrol® - Monotherapy in Patients With Idiopathic Parkinson's Disease
Study Start Date :
Feb 1, 2004
Actual Primary Completion Date :
Dec 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Idiopathic PD patients

Drug: Pramipexole
Other Names:
  • Sifrol®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in dosing details of Pramipexole [up to 21 months]

    2. Occurrence and clinical course of Parkinson Disease (PD) motor symptoms [up to 21 months]

    Secondary Outcome Measures

    1. Assessment of Kinetic Tremor [up to 21 months]

      Spiral test with at least five rotations from the centre to the edge in blinded fashion

    2. Change in dosing details of L-Dopa [up to 21 months]

    3. Global Assessment of tolerability by investigator on 4-point scale [after 21 months]

    4. Global assessment of efficacy by investigator on a 4-point scale [after 21 months]

    5. Number of patients with adverse drug reactions [up to 21 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of early stage idiopathic Parkinson's Disease

    • No pre-treatment with any dopaminergic treatment (de novo patients), or Pre-treatment with L-Dopa at doses of < 200 mg/d

    Exclusion Criteria:
    • Treating physicians are asked to consider the regulation described in the Summary of Product Characteristics (SmPC) for the treatment with pramipexole

    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:
    NCT02248181
    Other Study ID Numbers:
    • 248.539
    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