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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00721279
Other study ID # 248.655
Secondary ID
Status Completed
Phase N/A
First received July 23, 2008
Last updated May 19, 2014
Start date September 2007

Study information

Verified date May 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Austria: Federal Office for Safety in Health CareUnited States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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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Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
Sifrol® (pramipexole dihydrochloride)


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Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency Analysis for Baseline Pattern of RLS Symptoms 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. Baseline No
Primary Change in Total Scores of IRLS (International Restless Legs Rating Scale) 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.
Baseline and final visit (week12) No
Primary Change in Global Clinical Impression - Improvement (CGI-I) Scale 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 baseline and final visit (week 12) No
Primary Frequency of Adverse Events Frequency of patients with any adverse event, causally related adverse events and serious adverse events Up to 16 weeks No
Primary Correlation of the Change in IRLS at End of Titration and at Final Visit Correlation of the change in IRLS at end of titration and at final visit Up to 12 weeks No
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