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

Boehringer Ingelheim

Status: Completed

Conditions: Restless Legs Syndrome

Treatments: Drug: Pramipexole

Study type: Observational

Funder types: Industry

Identifiers

NCT02248155

248.618

Details and patient eligibility

About

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

Enrollment: 2,644 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

2,644 participants in 1 patient group

RLS patients

Treatment:

Drug: Pramipexole