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Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00721279
First received: July 23, 2008
Last updated: May 18, 2012
Last verified: May 2012
History of Changes

July 23, 2008
May 18, 2012
September 2007
October 2008   (final data collection date for primary outcome measure)
  • International Restless Legs Rating Scale [ Time Frame: Baseline and final visit (week12) ]
    The International Restless Legs Syndrome Rating Scale (IRLS) is a rating scale used to assess the severity of RLS symptoms. The IRLS consists of 10 items, each of which is rated from 0 to 4 points, higher values denoting an increased severity of symptoms. Maximum total score is 40. Score totals are grouped into four levels of severity: 1-10 points = mild RLS, 11-20 points = moderate RLS, 21-30 points = severe RLS, and 31-40 = very severe RLS
  • Global Clinical Impression - Improvement (CGI-I) Scale [ Time Frame: baseline and final visit (week 12) ]
    The Clinical Global Impression Improvement scale (CGI-I) requires the clinician to rate how much the patient's illness has improved or worsened relative to a baseline state. A patient's illness is compared to change over time and rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse
Evaluation of the treatment effect of pramipexole on RLS severity as measured by IRLS and CGI I Evaluation of the time to reaching maintenance dose of pramipexole [ Time Frame: 12 Weeks ]
Complete list of historical versions of study NCT00721279 on ClinicalTrials.gov Archive Site
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Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome
Sifrol Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary RLS

The objectives of the Post Market Surveillance (PMS) study are to evaluate the treatment effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International Restless Legs Rating Scale and Global Clinical Impression - Improvement, to evaluate the time to reaching maintenance dose of pramipexole
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Observational
Time Perspective: Prospective
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Non-Probability Sample

Patients with idiopathic RLS
  • Parkinson's Disease
  • Restless Legs Syndrome
Drug: Pramipexole immediate release
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
549
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October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Primary Restless Legs Syndrome (i.e. idiopathic RLS)
  • Indication for treatment with pramipexole
  • Male or female patients older than 18 years

Exclusion Criteria:

  • Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients
  • Current treatment with pramipexole
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00721279
248.655
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Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
May 2012

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