Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00539461
First received: September 28, 2007
Last updated: October 31, 2013
Last verified: October 2013

September 28, 2007
October 31, 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 ] [ Designated as safety issue: No ]
  • CGI-I responder rate after 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Time to reach maintenance dose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in RLS-QoL total score after 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
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 ] [ Designated as safety issue: No ]
  • Change in IRLS items after 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Final dose distribution [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Incidence, relationship and seriousness of adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Number of premature discontinuations [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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.
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

RLS patients

Restless Legs Syndrome
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2023
Not Provided
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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00539461
248.638
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Not Provided
Boehringer Ingelheim
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP