Multiple System Atrophy (MSA) with Orthostatic Hypotension (CYPRESS 0197)

The purpose of this study is to look at whether an investigational drug works and how safe it is when taken over several months to treat symptomatic neurogenic orthostatic hypotension (nOH, or low blood pressure upon standing and caused by the nervous system) in people with Multiple System Atrophy (MSA). The study will also look at the effects of the investigational drug on general well-being and if it can improve symptoms of nOH. 

Participation may last up to 126 weeks, and you will be asked to complete 12 study visits (in clinic and via telehealth). You will be asked to take the investigational drug or a placebo pill (an inactive pill), provide blood and urine samples, have physical/neurological examinations, have an electrocardiogram (ECG, or a test that measures the electrical activity of the heart), perform a 3-minute standing test and orthostatic (low blood pressure when standing up from sitting or lying down) standing test, optional tilt table test (a test to measure changes to your heart rate and blood pressure in response to changes in your posture), and answer questionnaires relating to your health. Participants will be compensated for completed visits.

In order to participate you must meet the following criteria:

• Are at least 30 years of age. 
• Have a diagnosis of possible or probable MSA of the Parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C) confirmed by the Enrollment Steering Committee (ESC). 
• Meet criteria for neurogenic orthostatic hypotension.
• Are willing to not take any prohibited medications during the study.

You will be excluded from the study if any of the following criteria apply to you:

• Have a systemic illness known to produce autonomic neuropathy, including, but not limited to, amyloidosis and autoimmune neuropathies. Participants with diabetes mellitus (DM) will be evaluated on a case-by-case basis. 
• Have a known intolerance to other norepinephrine reuptake inhibitors (NRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs). 
• Are currently using concomitant antihypertensive medication for the treatment of essential hypertension or have a de novo diagnosis of arterial hypertension at Screening.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.