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news.UCB has announced positive results based on the first-line analyses of its Phase IIa clinical trial with lacosamide to treat fibromyalgia syndrome.
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The initial results from this proof of concept study showed activity of lacosamide in fibromyalgia syndrome but require further analysis. A decision to start Phase IIb will be made by the end of 2008.
This lacosamide trial was randomized, placebo-controlled and double-blind to assess efficacy and safety of 400mg/day lacosamide tablets in patients suffering from signs and symptoms associated with fibromyalgia syndrome (FMS).
This trial was designed to establish a signal to provide justification for further clinical development of lacosamide in FMS.
The primary variable was a within-subject change in average daily pain score from baseline to the last two weeks of the treatment phase using an 11-point Likert scale. Based on 158 patients (randomized) of the full analysis set, an effect size of 0.5 in favour of lacosamide versus placebo was observed for the primary variable. Lacosamide was generally very well tolerated.