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First assessment of individual RLS domains in new post-hoc analyses of Neupro® studies
Date:4/25/2012

ATLANTA, April 25, 2012 /PRNewswire/ -- New post-hoc analyses of pivotal clinical trials of Neupro® (rotigotine transdermal system) in patients with Restless Legs Syndrome (RLS)/Willis Ekbom disease analysed the severity and impact of RLS symptoms using changes in individual International RLS Study Group Rating Scale (IRLS)  item scores. Improvements with rotigotine versus placebo were observed in most of the single items from the IRLS, which measures sensory-motor dysfunction, severity of sleep disturbance, and impact of RLS on daily activities. The findings from the post-hoc analyses of the two pivotal trials carried out in US and Europe were presented today at the 64th American Academy of Neurology (AAN) Annual Meeting in New Orleans, LA.

"The total score of the IRLS is usually reported in clinical trials. These post-hoc analyses used a new approach and evaluated the core symptoms of RLS using single item data from the IRLS," said Dr. Richard Allen, Johns Hopkins University, Baltimore, MD. "The results suggested that rotigotine's effects appear to be related both to its broad action in improving core RLS symptoms and on reducing impact on sleep and daily activities.  Additional prospective studies are needed to further our understanding in this area."

The post-hoc analyses were based on data from the two phase III, double-blind, 6 month placebo-controlled trials (SP792 in the U.S. [NCT00135993] and SP790 in Europe [NCT00136045]). They investigated the effect of rotigotine on specific features of RLS by examining single item scores from IRLS related to core RLS symptoms (sensory-motor dysfunction), degree of severity (days and hours within day with symptom), and symptom impact on sleep, mood and daily life.

The IRLS total score consists of 10 single items:

  • Item 1: RLS discomfort in legs or arms
  • Item 2: need to move around due to RLS symptoms
  • Item 3: relief
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