Two large, randomised, placebo-controlled studies presented at the inaugural conference of the World Association of Sleep Medicine (WASM; Berlin, Germany) in October demonstrate that pramipexole delivered both short-term and sustained efficacy in patients suffering from Restless Legs Syndrome (RLS)1,2 enrolled in these trials.

New data from a randomized, placebo-controlled "withdrawal" study1 show that discontinuation of pramipexole leads to rapid worsening of RLS in patients who had previously responded well to pramipexole therapy. In this study, RLS patients who responded to pramipexole treatment in a preceding 6-month open label treatment phase were randomized to receive either blinded pramipexole (n=78) or placebo (n=69) for 12 weeks. The primary endpoint of the study was assessment of 'Time to Worsening' of RLS symptoms measured using the International RLS Rating Scale (IRLS) and the Clinical Global Impressions Global Improvement (CGI-I) scale. The results showed:

• RLS patients who were randomized to continue treatment with pramipexole experienced a significantly longer time before their symptoms worsened than those patients who were randomised to placebo (p<0.0001)
• The proportion of patients that experienced worsening of their RLS symptoms in the blinded pramipexole group was statistically significantly smaller compared to those randomized to receive placebo (pramipexole 20.5 percent vs. placebo 85.5 percent; p<0.0001)
• One week after randomization, more than 70.0 percent of patients on placebo worsened as compared to just 9.0 percent of patients in the blinded pramipexole group
• Pramipexole also significantly improved the disease-specific quality of life score to 90 percent (70 percent for placebo; p<0.0001)

In addition, in a fixed-dose study pramipexole demonstrated significant improvement in symptoms of RLS, when measured by two standard clinical assessment tools, when compare
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Contact: Anne Marie Kearns
annemarie.kearns@ketchum.com
646-935-4010
Ketchum
9-Dec-2005

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