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

Boehringer Ingelheim2,644 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

2,644

Conditions

Restless Legs Syndrome

Interventions

PramipexoleDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: up to 12 weeks

Change from Baseline in WPAI by means of a patient questionnaire

Time frame: Baseline, 12 weeks

Secondary Outcomes

Number of patients with adverse drug reactions

Time frame: up to 12 weeks

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

Time frame: after 12 weeks

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

Time frame: up to 12 weeks

Time to reach pramipexol maintenance dose

Time frame: up to 12 weeks

Data from ClinicalTrials.gov

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