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news.Chelsea Therapeutics International has initiated patient dosing in study 302, the first of two pivotal Phase III trials designed to demonstrate efficacy and support US marketing of approval of Droxidopa in neurogenic orthostatic hypotension.
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Study 302 is a randomized, placebo-controlled, parallel-group, withdrawal-design Phase III study with an initial open-label dose titration and seven day open-label treatment period, followed by a 14-day double-blind randomized withdrawal period. The primary endpoint will be the relative symptomatic change, as measured by the mean score of Item 1 (dizziness or light-headedness) of the Orthostatic Hypotension Symptom Assessment (OHSA), 14 days following randomization either to continued therapy with Droxidopa or to placebo.
Study 302 is approximately 5 weeks in duration, including the titration period which could be up to 2 weeks depending on dose response. Both pivotal trials (Studies 301 and 302) will evaluate up to 118 patients, for a combined total of up to 236 patients. Chelsea currently expects to activate approximately 35 North American sites and 15 European sites in each study to allow for broad participation from key opinion leaders while simultaneously expediting enrollment.
It is anticipated that both pivotal studies (301 & 302) will be completed by year-end 2008, allowing for a new drug application (NDA) to be filed with the FDA early in 2009. Patients from Study 302 will also be eligible to enter a renewable three-month extension program (Study 303) to supplement existing safety data.