Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome
|ClinicalTrials.gov Identifier: NCT00721279|
Recruitment Status : Completed
First Posted : July 24, 2008
Results First Posted : January 8, 2010
Last Update Posted : June 4, 2014
|Condition or disease||Intervention/treatment|
|Restless Legs Syndrome||Drug: Sifrol® (pramipexole dihydrochloride)|
|Study Type :||Observational|
|Actual Enrollment :||549 participants|
|Official Title:||Sifrol Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary RLS|
|Study Start Date :||September 2007|
|Primary Completion Date :||October 2008|
- Frequency Analysis for Baseline Pattern of RLS Symptoms [ Time Frame: Baseline ]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) ]
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) ]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 ]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 ]Correlation of the change in IRLS at end of titration and at final visit
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00721279
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|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|