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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Pramipexole

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