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Non-interventional Observational Study of Pramipexole in Restless Legs Syndrome: Impact on Quality of Life

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ClinicalTrials.gov Identifier: NCT00539461
Recruitment Status : Completed
First Posted : October 4, 2007
Last Update Posted : November 1, 2013
Information provided by:

September 28, 2007
October 4, 2007
November 1, 2013
February 2007
November 2007   (Final data collection date for primary outcome measure)
  • Change from baseline in IRLS total score after 12 weeks [ Time Frame: 12 weeks ]
  • CGI-I responder rate after 12 weeks [ Time Frame: 12 weeks ]
  • Time to reach maintenance dose [ Time Frame: 12 weeks ]
  • Change from baseline in RLS-QoL total score after 12 weeks [ Time Frame: 12 weeks ]
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Complete list of historical versions of study NCT00539461 on ClinicalTrials.gov Archive Site
  • Change from baseline in IRLS score after 1-4 weeks [ Time Frame: 4 weeks ]
  • Change in IRLS items after 12 weeks [ Time Frame: 12 weeks ]
  • Final dose distribution [ Time Frame: 12 weeks ]
  • Incidence, relationship and seriousness of adverse events [ Time Frame: 12 weeks ]
  • Number of premature discontinuations [ Time Frame: 12 weeks ]
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Non-interventional Observational Study of Pramipexole in Restless Legs Syndrome: Impact on Quality of Life
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.
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Time Perspective: Prospective
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Non-Probability Sample
RLS patients
Restless Legs Syndrome
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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November 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Diagnosis of primary RLS
  2. Indication for RLS treatment with Sifrol® (pramipexole)
  3. Male or female patients aged at least 18 years.

Exclusion Criteria:

  1. Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients.
  2. Ongoing treatment with Sifrol® (pramipexole).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
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Boehringer Ingelheim
October 2013