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Observational Study of Sifrol® in Patients With Primary Restless Legs Syndrome (RLS)

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT02248155
Collaborator
(none)
2,644
Enrollment

Study Details

Study Description

Brief Summary

The objectives of this Post Marketing Surveillance (PMS) are:

  • Evaluation of the treatment effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International Restless Legs Syndrome Scale (IRLS) and Clinical Global Impression Improvement scale (CGI- I)

  • Evaluation of the time to reaching maintenance dose of pramipexole

  • Evaluation of work productivity impairment associated with RLS based on the Work Productivity and Activity Impairment Questionnaire (WPAI) questionnaire

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
2644 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Sifrol® Onset of Action and Impact on RLS: A 12-week Observational Study in Patients With Primary RLS
Study Start Date :
Apr 1, 2006
Actual Primary Completion Date :
Nov 1, 2006

Arms and Interventions

Arm Intervention/Treatment
RLS patients

Drug: Pramipexole
Other Names:
  • Sifrol®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Assessment of RLS symptoms (IRLS) on a 4-point rating scale [up to 12 weeks]

    2. Change from Baseline in WPAI by means of a patient questionnaire [Baseline, 12 weeks]

    Secondary Outcome Measures

    1. Number of patients with adverse drug reactions [up to 12 weeks]

    2. Global assessment of efficacy by investigator on a 5-point scale [after 12 weeks]

    3. Change in Clinical Global Impression Improvement (CGI-I) rated on a 7-point scale [up to 12 weeks]

    4. Time to reach pramipexol maintenance dose [up to 12 weeks]

    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 primary RLS who are eligible for Pramipexol (PPX) treatment could be included into the study

    • Patients not pre-treated with any dopaminergic agent (de novo patients) or patients pre-treated with dopaminergic medication

    • Male of female patients of any age

    Exclusion Criteria:
    • The treating physicians are asked to consider the regulations 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:
    NCT02248155
    Other Study ID Numbers:
    • 248.618
    First Posted:
    Sep 25, 2014
    Last Update Posted:
    Sep 25, 2014
    Last Verified:
    Sep 1, 2014
    Additional relevant MeSH terms:
    Psychomotor Agitation
    Restless Legs Syndrome
    Syndrome
    Pramipexole

    Study Results

    No Results Posted as of Sep 25, 2014