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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Restless Legs Syndrome

Intervention: Pramipexole (Drug)

Phase: N/A

Status: Completed

Sponsored by: Boehringer Ingelheim

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

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Assessment of RLS symptoms (IRLS) on a 4-point rating scale

Change from Baseline in WPAI by means of a patient questionnaire

Secondary outcome:

Number of patients with adverse drug reactions

Global assessment of efficacy by investigator on a 5-point scale

Change in Clinical Global Impression Improvement (CGI-I) rated on a 7-point scale

Time to reach pramipexol maintenance dose

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: April 2006
Last updated: September 22, 2014

Page last updated: August 23, 2015

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