), 'Social Functioning' (i.e. interference with normal social activities with family, friends and others) and 'Bodily Pain' (i.e. bodily pain during the past four weeks on a six-point verbal rating scale). For the other five subscales (physical functioning, role limitations due to physical problems, role limitations due to emotional problems, general mental health, and general health perceptions), pramipexole showed an improvement on scores over placebo, but these data did not reach statistical significance. These data are important as recent studies have shown that the Quality of Life impact of RLS is comparable to that of other chronic diseases such as hypertension, diabetes, and other cardiovascular conditions.

Previous studies in RLS have suggested that pramipexole may provide rapid relief from symptoms. The efficacy and safety of pramipexole has been studied from a starting dose of 0.125mg single dose per day and up to 0.75mg single dose per day.

Two pivotal studies of pramipexole in RLS have showed significant short- and long-term efficacy versus placebo. These and other trials are part of a comprehensive clinical trial program, involving more than 1,000 patients, to assess the therapeutic potential of pramipexole in this indication. Boehringer Ingelheim, the discoverer of the molecule, has also recently submitted applications for international regulatory approval of pramipexole in the treatment of RLS.

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Contact: Anne Marie Kearns
annemarie.kearns@ketchum.com
646-935-4010
Ketchum
9-Dec-2005

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