Restless Legs Syndrome Clinical Trial
Official title:
Sifrol® (Pramipexole) Impact on RLS Related Quality of Life: A 12-weeks Observational Study in Patients With Primary RLS
In this German non-interventional observational study 1980 patients diagnosed with Restless
Legs Syndrome (RLS) will be investigated by 990 General Practitioners across all federal
states in Germany. Both moderate to severe RLS patients, with or without previous RLS
treatment, suffering from RLS symptoms like a desire to move the extremities usually
associated with some discomfort, motor restlessness and worsening of symptoms at rest with
at least temporary relief by activity, worsening of symptoms later in the day or at night,
are eligible for this study, if it is planned to initiate therapy with pramipexole or to add
pramipexole to a previously given, insufficient therapy. Three visits are planned to be
documented in this PMS study, one baseline visit, visit two after the end of pramipexole
titration and visit three after 12 weeks of treatment. Evaluations and visits are to be
carried out and documented only if part of routine medical practice. The main goal of
observational studies is to determine how pramipexole treatment works when applied in actual
practice and thus maximise external validity. In actual practice patients who have been
excluded in the clinical registration trials of PPX in moderate to severe primary RLS (i.e.
those with certain disease histories, co-morbidities and/or demographic characteristics)
will be treated with PPX. Thus in addition during this observational study information on
the efficacy and safety of PPX in those patients will be obtained. The objectives of this
PMS study are:
- To evaluate the treatment effect of pramipexole on RLS severity and general improvement
as measured by IRLS and CGI-I.
- To evaluate quality of life of RLS patients as measured by the Restless Legs Syndrome
Quality of Life questionnaire (RLS-QoL).
- To evaluate the safety profile of PPX in a natural study population.
n/a
Time Perspective: Prospective
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|---|---|---|---|
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