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Efficacy and Tolerability of Sifrol® (Pramipexole) in Patients With Advanced Idiopathic Parkinson's Disease

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT02248220
Collaborator
(none)
657
Enrollment

Study Details

Study Description

Brief Summary

Assessment of daily maintenance dose of Sifrol®, L-dopa sparing effect, effect on tremor, depression, anhedonia and tolerability

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
657 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Observation of the Efficacy and Tolerability of Sifrol® (Pramipexole) in Patients With Advanced Idiopathic Parkinson's Disease
Study Start Date :
Oct 1, 1998
Actual Primary Completion Date :
Oct 1, 1999

Arms and Interventions

Arm Intervention/Treatment
Parkinson's disease patients

Drug: Pramipexole
Other Names:
  • Sifrol®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in cumulative daily doses of Sifrol® [up to 8 weeks]

      Changes in the doses between visits are evaluated using Wilcoxon's signed rank test

    2. Changes in cumulative daily doses of L-dopa [up to 8 weeks]

      Changes in the doses between visits are evaluated using Wilcoxon's signed rank test

    Secondary Outcome Measures

    1. Change from Baseline in Short Parkinson Evaluation Scale (SPES) total score [Baseline, after 8 weeks]

    2. Change from Baseline in SPES subscales [Baseline, after 8 weeks]

      Psychopathological disturbances, Activities of daily living, Evaluation of motor function, Tremor, Resting Tremor, Postural tremor, Complications of therapy

    3. Change from Baseline in Snaith-Hamilton-Pleasure-Scale total score [Baseline, after 8 weeks]

      patients with SPES depression >= 2

    4. Change from Baseline in Tremor Impact Scale (TIS-D) total score [Baseline, after 8 weeks]

    5. Change from Baseline in global Parkinson's Disease (PD) symptoms [Baseline, after 8 weeks]

      Akinesia, anhedonia, depression, dyskinesia, motor fluctuation, cognitive disturbances, rigor and tremor

    6. Global assessment of efficacy by investigator on a 5-point scale [after 8 weeks]

    7. Global assessment of tolerability by investigator on a 5-point scale [after 8 weeks]

    8. Number of patients with adverse events [up to 8 weeks]

    9. 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 advanced idiopathic Parkinson's disease for whom combined treatment with Sifrol and L-dopa was indicated
    Exclusion Criteria:
    • NA

    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:
    NCT02248220
    Other Study ID Numbers:
    • 248.360
    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