Observational Study of Sifrol® in Patients With Primary Restless Legs Syndrome (RLS)
- Registration Number
- NCT02248155
- Lead Sponsor
- Boehringer Ingelheim
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2644
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description RLS patients Pramipexole -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Time to reach pramipexol maintenance dose up to 12 weeks Number of patients with adverse drug reactions up to 12 weeks Change in Clinical Global Impression Improvement (CGI-I) rated on a 7-point scale up to 12 weeks Global assessment of efficacy by investigator on a 5-point scale after 12 weeks