Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome
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
|Study Design:||Time Perspective: Prospective|
|Official Title:||Sifrol Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary RLS|
- 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
|Study Start Date:||September 2007|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00721279
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|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|