The Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure Aim 2 of RDCRN (Rare Diseases Clinical Research Network) Project 2

Who is this study for? Patients with Autonomic Failure, Pure Autonomic Failure
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
United States
Tennessee
Autonomic Dysfunction Center/ Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
Bonnie K Black, RN
autonomics@vumc.org
615-343-6862
Backup
Luis E Okamoto, MD
autonomics@vumc.org
615-936-6119
Time Frame
Start Date: 2016-09
Estimated Completion Date: 2026-12
Participants
Target number of participants: 34
Treatments
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.
Authors
David Robertson
Sponsors
Leads: Vanderbilt University Medical Center

This content was sourced from clinicaltrials.gov