Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome
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|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|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00721279
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|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|