Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Chelsea Therapeutics International has received approval from the UK's Medicines and Healthcare products Regulatory Agency to begin a Phase II trial of Droxidopa, alone and in combination with carbidopa, for the treatment of fibromyalgia.
Subscribe to our email newsletter
To evaluate the role of norepinephrine (NE) in fibromyalgia and the safety and efficacy of Droxidopa in this indication, Chelsea intends to conduct an exploratory Phase II trial of Droxidopa, both alone and in combination with carbidopa in 120 fibromyalgia patients.
Chelsea intends to initiate a multi-centre, randomized, double-blind, placebo-controlled, dose response, factorial 12-arm parallel group Phase II trial in September 2008. The 12-arm trial will evaluate 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 600 mg 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. Results from this trial are expected to be available in 2010.