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 (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00721279
First received: July 23, 2008
Last updated: May 19, 2014
Last verified: May 2014

July 23, 2008
May 19, 2014
September 2007
October 2008   (final data collection date for primary outcome measure)
  • Frequency Analysis for Baseline Pattern of RLS Symptoms [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Severity of RLS was rated using the International RLS Severity Scale. This scale measures the severity of RLS symptoms and comprises of 10 questions with 5 possible answers, each answer scored from 0-4 points and is classified into 5 RLS severity groups: 0 points = no symptoms, 1-10 points = mild, 11-20 points = moderate, 21-30 points = severe, 31-40 points = very severe.
  • Change in Total Scores of IRLS (International Restless Legs Rating Scale) [ Time Frame: Baseline and final visit (week12) ] [ Designated as safety issue: No ]

    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.

    The change from baseline was calculated as baseline minus the week 12 value.

  • Change in Global Clinical Impression - Improvement (CGI-I) Scale [ Time Frame: baseline and final visit (week 12) ] [ Designated as safety issue: No ]
    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
  • Frequency of Adverse Events [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
    Frequency of patients with any adverse event, causally related adverse events and serious adverse events
  • Correlation of the Change in IRLS at End of Titration and at Final Visit [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    Correlation of the change in IRLS at end of titration and at final visit
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

Restless Legs Syndrome
Drug: Sifrol® (pramipexole dihydrochloride)
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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
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
May 2014

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