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New treatment option for Autonomic Failure
Official title Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure
ClinicalTrials.gov ID: NCT02897063
What this study is testing
What is Droxidopa?
Droxidopa is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for autonomic failure.
Also referred to as Northera.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to learn more about the effects of midodrine and droxidopa, two medications used for the treatment of orthostatic hypotension (low blood pressure on standing), on the veins of the abdomen of patients with autonomic failure. The study will be conducted at Vanderbilt University Medical Center, and consists of 2 parts: a screening and 2 testing days.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- Male and female people, age 40-80 years with possible or probable Multiple System Atrophy, Pure Autonomic Failure, or Parkinson disease, as defined...
- Neurogenic orthostatic hypotension defined as a ≥30-mmHg decrease in systolic blood pressure within 3 minutes of standing associated with impaired...
- people able and willing to provide informed consent.
You likely can't join if
- Supine hypertension, defined as systolic blood pressure of ≥ 160 mmHg measured on two separate occasions.
- Pregnancy.
- Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathies, and...
- History of known aortic aneurisms, thoracic, abdominal or pelvic surgery in the past 6 months.
- Symptomatic abdominal or inguinal hernias.
- Severe gastroesophageal reflux.
See the full eligibility criteria
- Male and female people, age 40-80 years with possible or probable Multiple System Atrophy, Pure Autonomic Failure, or Parkinson disease, as defined by Consensus Criteria.
- Neurogenic orthostatic hypotension defined as a ≥30-mmHg decrease in systolic blood pressure within 3 minutes of standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of...
- people able and willing to provide informed consent.
- Supine hypertension, defined as systolic blood pressure of ≥ 160 mmHg measured on two separate occasions.
- Pregnancy.
- Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathies, and autoimmune neuropathies.
- History of known aortic aneurisms, thoracic, abdominal or pelvic surgery in the past 6 months.
- Symptomatic abdominal or inguinal hernias.
- Severe gastroesophageal reflux.
- Recent fractures or fissures of ribs, thoracic or lumbar spine.
- Medical devices implanted on the abdominal wall or abdomen that would interfere with the abdominal compression.
- Intolerance to any increase in intraabdominal pressure.
- Clinically unstable coronary artery disease or major cardiovascular or neurological event in the past 6 months, and other factors which in the investigator's opinion would prevent the subject from completing the...
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.