Restless Legs Syndrome Clinical Trial
Official title:
Non-interventional Observational Study on the Influence of Pramipexole (PPX) on Sensory Symptoms of Restless Legs Syndrome (RLS)
The main goal of this open-label, prospective, non-controlled, non-interventional post
marketing surveillance study is to evaluate how pramipexole treatment works when applied in
actual practice. In actual practice patients who would have been excluded in the clinical
registration studies of pramipexole in moderate to severe primary Restless Legs Syndrome
(i.e. those with certain disease histories, co-morbidities and/or demographic
characteristics) will also be treated with pramipexole. Thus, during this post marketing
surveillance study additional information on the efficacy and safety of pramipexole in those
patients will be obtained. The objectives of this post marketing surveillance study are:
- To investigate the influence of Sifrol® (pramipexole) treatment on unpleasant sensory
symptoms of Restless Legs Syndrome as measured with the short form of the McGill Pain
Questionnaire.
- To assess if improvement of sensory symptoms correlates with overall Restless Legs
Syndrome severity (International Restless Legs Syndrome Scale for Severity) and with
secondary symptoms like sleeping problems and daytime tiredness (items 1 & 6 from
Restless Legs Syndrome-6).
- To evaluate if the treatment effect of Sifrol on overall Restless Legs Syndrome
severity (International Restless Legs Syndrome Scale for Severity) differs between
patients with high pain scores and patients with lower pain scores.
- To compare General Practitioner and neurologist sites patient populations in terms of
demographics, Restless Legs Syndrome severity at Visit 1 and treatment outcomes at
Visit 3.
- To evaluate the development of behavioural changes under pramipexole treatment.
Study Design: ;
Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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