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news.Chelsea Therapeutics International, a biopharmaceutical development company, has initiated a Phase II trial of droxidopa, a synthetic precursor of norepinephrine, both alone and in combination with carbidopa for the treatment of fibromyalgia.
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The Phase II trial, being conducted in the UK, is a multi-center, randomized, double-blind, placebo-controlled, dose response, factorial 12-arm parallel group study evaluating 120 patients equally randomized to receive droxidopa monotherapy, carbidopa monotherapy, droxidopa/carbidopa combination therapy or placebo.
Accordingly, 10 patients will be randomized into each of 12 groups to receive: 200mg, 400mg or 600mg of droxidopa TID; 25mg or 50mg carbidopa TID; 200/25mg, 400/25mg or 600/25mg droxidopa/carbidopa TID; 200/50mg, 400/50mg or 600/50mg droxidopa/carbidopa TID; or placebo over a nine-week treatment period.
The primary endpoint will be the average reduction in pain as measured by the short form McGill pain questionnaire. Secondary outcomes of the study include fibromyalgia index questionnaire, patient global impression of change, multidimensional fatigue inventory and Hamilton anxiety depression survey.
Ernest Choy, lead investigator of the study, said: The unique design of this trial should allow us to not only explore the role and potential therapeutic application of norepinephrine in fibromyalgia, but, by pairing droxidopa with carbidopa to limit peripheral metabolism of droxidopa into norepinephrine, should also allow us to more closely examine the central effect of norepinephrine in this indication.