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Belgian pharmaceutical group UCB has announced results based on first-line analyses of its phase IIa clinical trial with lacosamide to treat fibromyalgia syndrome.
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 the year.
This lacosamide trial was randomised, 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. 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 (randomised) 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.
Lacosamide has been filed with the US FDA and the EMEA for the treatment of epilepsy and diabetic neuropathic pain.