Recruiting
Phase 1

Midodrine & Droxidopa

Sponsor:

Vanderbilt University Medical Center

Code:

NCT02897063

Conditions

Autonomic Failure

Pure Autonomic Failure

Multiple System Atrophy

Parkinson Disease

Orthostatic Hypotension

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Droxidopa

Midodrine

Placebo

Study Details

Brief summary:

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. The total length of the study will be about 5 days. About 34 participants will be screened for the study.

Conditions

Autonomic Failure

Pure Autonomic Failure

Multiple System Atrophy

Parkinson Disease

Orthostatic Hypotension

Study ID

NCT02897063

Start date

Sep, 2016

Status verified date

Dec, 2024

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male and female subjects, 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 other identifiable causes.
  • Subjects able and willing to provide informed consent.

Exclusion Criteria:

  • 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 protocol including clinically significant abnormalities in clinical, mental or laboratory testing.

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Droxidopa and Placebo

Patients will be studied on two separate days, two days apart: one day with the active drug and one day with placebo. The order of the study days will be randomized. On each study day, patients will receive a single oral dose of either droxidopa 300 mg or placebo after the first tilt table test, followed two hours later by a single oral dose of placebo.

experimental: Midodrine and Placebo

Patients will be studied on two separate days, two days apart: one day with the active drug and one day with placebo. The order of the study days will be randomized. On each study day, patients will receive a single oral dose of placebo after the first tilt table test, followed two hours later by a single oral dose of either midodrine 10 mg or placebo.

Interventions

Droxidopa

Single oral dose 300 mg

Midodrine

Single oral dose 10 mg

Placebo

sugar pill

Primary outcome measure

  • Stroke volume [ Time Frame: Up to 10 min of head up tilt ]

Central Contacts and Locations

Central contacts

Bonnie K Black, RN

615-343-6862autonomics@vumc.org

Luis E Okamoto, MD

615-936-6119autonomics@vumc.org

Locations

Autonomic Dysfunction Center/ Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Emily C Smith, RN

615.875.1516autonomics@vumc.org

Bonnie K Black, RN

615-322-3304autonomics@vumc.org

Principal Investigator:

Italo Biaggioni, MD

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Oct 14, 2025

Last verified

Dec, 2024

Keywords

  • midodrine
  • droxidopa
  • splanchnic circulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2025-10-14.