Chelsea Therapeutics Announces First Patient Dosed in NORTHERA Study 401 for Treatment of Symptomatic nOH

Chelsea Therapeutics CHTP today announced that the first patient has been dosed in Study 401, a multi-center, multi-national, randomized, parallel-group, placebo-controlled, double-blind study of investigational drug NORTHERA™ (droxidopa), an orally active synthetic precursor of norepinephrine, being studied for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy. The Company expects Study 401 to enroll approximately 450 patients. Study 401 will evaluate the clinical efficacy and safety of Northera versus placebo over a 17 week (maximum) treatment period consisting of an initial, open-label dose titration (up to 2 weeks), followed by a washout period (up to 3 weeks), followed by a 12 week treatment period on a stable dose. The primary outcome measure of the study is to evaluate the duration of clinical benefit of Northera as demonstrated by the change in the Orthostatic Hypotension Symptom Assessment (OHSA) Item 1, which includes symptoms of dizziness and lightheadedness. Secondary outcome measures include patient reported falls, standing blood pressure change, and other efficacy measures, including the orthostatic hypotension questionnaire (OHQ) composite and individual See full press release