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

September 22, 2014 updated by: Boehringer Ingelheim

Sifrol® Onset of Action and Impact on RLS: A 12-week Observational Study in Patients With Primary RLS

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2644

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients suffering from moderate to severe RLS recruited at office-based general practitioners and interists

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RLS patients
Drug: Pramipexole
Other Names:
  • Sifrol®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of RLS symptoms (IRLS) on a 4-point rating scale
Time Frame: up to 12 weeks
up to 12 weeks
Change from Baseline in WPAI by means of a patient questionnaire
Time Frame: Baseline, 12 weeks
Baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Clinical Global Impression Improvement (CGI-I) rated on a 7-point scale
Time Frame: up to 12 weeks
up to 12 weeks
Global assessment of efficacy by investigator on a 5-point scale
Time Frame: after 12 weeks
after 12 weeks
Number of patients with adverse drug reactions
Time Frame: up to 12 weeks
up to 12 weeks
Time to reach pramipexol maintenance dose
Time Frame: up to 12 weeks
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

September 22, 2014

First Submitted That Met QC Criteria

September 22, 2014

First Posted (Estimate)

September 25, 2014

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 22, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 248.618

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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