Chelsea Therapeutics Reports Subgroup Analysis of 44 Parkinson's Patients in Study 302 Shows Highly Statistically Significant Benefits of Droxidopa Therapy
Globe Newswire, December 14, 2009: 07:30 AM ET
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CHARLOTTE, N.C., Dec. 14, 2009 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that new data from a subgroup analysis of the 44 Parkinson's Disease (PD) patients enrolled in Study 302, a Phase III withdrawal study of
Droxidopa for the treatment of symptomatic neurogenic orthostatic hypotension (NOH), demonstrated a more robust response compared to the overall study population. Study investigators presented these data during a symposium at the XVIII WFN World Congress on Parkinson's Disease and Related Disorders in Miami.
Study 302 evaluated the efficacy and safety of Droxidopa, a pro-drug that results in increased body stores of norepinephrine, in 101 patients with symptomatic NOH. All patients in Study 302 were evaluated for functional and symptomatic improvement through multiple endpoints including the orthostatic hypotension questionnaire (OHQ). The OHQ is a global measure of disease activity consisting of a two-part questionnaire that includes the six-item orthostatic hypotension symptom assessment scale (OHSA) and the four-item orthostatic hypotension daily activities scale (OHDAS), along with corresponding OHSA, OHDAS and OHQ composite scores.