Restless Legs Syndrome
Conditions
Brief 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
Interventions
DRUGPramipexole
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of RLS symptoms (IRLS) on a 4-point rating scale | up to 12 weeks |
| Change from Baseline in WPAI by means of a patient questionnaire | Baseline, 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with adverse drug reactions | up to 12 weeks |
| Global assessment of efficacy by investigator on a 5-point scale | after 12 weeks |
| Change in Clinical Global Impression Improvement (CGI-I) rated on a 7-point scale | up to 12 weeks |
| Time to reach pramipexol maintenance dose | up to 12 weeks |
Outcome results
None listed