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
Read full item here: http://money.cnn.com/news/newsfeeds/...ire/180213.htm

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.

I am in this study and have benefited greatly from this drug. The study has been extended for another 12-18 months. I beilieve the reason is that the pool of particaipants was not large enough and the FDA required more info. It will be especially useful for PD patients with low bood pressure that drops when you stand up, etc. I suffered with dizziness, fainting, nausea and vomiting until I began this study. I am doing much better and able to function daily.