In 2014, the U.S. Food and Drug Administration (FDA) approved the study drug droxidopa for, “the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic OH caused by...Parkinson’s disease, multiple system atrophy, pure autonomic failure, dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been demonstrated. The continued effectiveness of droxidopa should be assessed periodically.” The purpose of the current trial is to assess the effectiveness of the study drug to treat symptoms of nOH beyond 2 weeks.
All participants will receive the study drug for up to 16 weeks during the “open-label” portions of the study. This will help your study doctor determine your optimal dose of study drug. Participants will then receive either the study drug or a matching placebo during the 12-week, “double-blind” portion of the trial (a placebo is a pill that contains no active drug;“double-blind” means that neither you nor the study doctor will know if you are taking the study drug or placebo).
Always ask your physician about the potential side effects you may experience when participating in a clinical trial.
Should you decide to participate in this study, you may choose to discontinue your participation at any time, for any reason.
Please note that this study is currently being conducted in the United States only.