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RESTORE: A clinical study of patients with symptomatic neuRogenic orthostatic hypotEnsion to assess Sustained effecTs Of dRoxidopa thErapy

This is a multi-site, placebo-controlled, double-blind, time to intervention study designed to evaluate the clinical efficacy and safety of droxidopa versus placebo over a 12-week double-blind treatment period in patients with symptomatic NOH who have previously received up to 16 weeks of open-label treatment with an individually optimized dose of droxidopa (randomized withdrawal design).
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Symptomatic neurogenic orthostatic hypotension associated with: (1) primary autonomic failure (Parkinson’s Disease, Multiple System Atrophy, Pure Autonomic Failure), (2) Non-Diabetic Autonomic Neuropathy, or (3) Dopamine Beta Hydroxylase deficiency
Able to stand, with or without limited assistance
Exclusion Criteria:
History of heart attack within the past 2 years, congestive heart failure (class 3 or 4), or uncontrolled cardiac arrhythmia
High blood pressure that requires treatment with blood pressure medication
History of cancer within the past 2 years (some exceptions can be discussed)
Diabetic autonomic neuropathy
Women who are pregnant or breastfeeding
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Hershey, PA