WHO IS ELIGIBLE TO PARTICIPATE IN THIS CLINICAL TRIAL?
To participate in this clinical trial you must meet certain criteria, including:
- At least 18 years of age
- Have nOH associated with PD, MSA, PAF, DBH Deficiency or NDAN
- Do not have a diagnosis of hypertension (high blood pressure) that requires treatment with medications to lower your blood pressure
- Do not have a history of cancer in the last two years
- Do not have congestive heart failure
Individuals currently taking droxidopa prescribed by their doctor are eligible to participate.
QUALIFIED STUDY PARTICIPANTS WILL:
- Attend up to 15 visits at the trial site and participate in 3 visits via telephone. The study will last up to a maximum of 36 weeks
- Receive study-related medical exams and study drug throughout the study at no cost
- Complete questionnaires about their nOH symptoms during site visits
- Provide blood draws and urine samples for laboratory tests
WHAT DRUG IS BEING STUDIED IN THIS CLINICAL TRIAL?
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.