Clinical Trial TitleA clinical study of patients with symptomatic neurogenic orthostatic hypotension to assess sustained effects of droxidopa therapy (RESTORE).
Clinical Trial Protocol Description:
The purpose of this research study is to evaluate the effectiveness and safety of a study drug called droxidopa (also known by the trade name NORTHERA) in people with symptoms of neurogenic orthostatic hypotension (NOH). It is anticipated that 482 subjects will participate in this study at approximately 125 centers (at least 4 at Rush University Medical Center). If you agree and are eligible to participate your participation may last up to 36 weeks. You will be asked to come to the medical center for some of the study visits and other study visits may be done by phone or video calls. The study consists of three phase an open-label dose finding phase (up to 4 weeks), an open-label treatment phase period (12 weeks) where your will receive active study drug; followed by a double-blind phase (up to 12 weeks) where you will be randomized to either study drug or placebo (inactive, sugar pill).
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years or older and able to walk at least 10 meters.
- Have a clinical diagnosis of symptomatic orthostatic hypotension associated with Primary Autonomic Failure (PD, MSA, and PAF) or dopamine beta hydroxylase deficiency.
- Are able to provide written informed consent.
You will be excluded from the study if any of the following criteria apply to you:
- Have sustained supine hypertension greater than or equal to 180 mmHg systolic or 110 mmHg diastolic.
- Have a diagnosis of hypertension that requires treatment with antihypertensive medications.
- Have any significant uncontrolled cardiac arrhythmia.
- Have a history of myocardial infarction, within the past 2 years.
This is a partial list of inclusion and exclusion criteria.