Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT02897063
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Autonomic Failure
  • Multiple System Atrophy
  • Orthostatic Hypotension
  • Parkinson Disease
  • Pure Autonomic Failure

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Droxidopa — DRUG
    Single oral dose 300 mg
  • Midodrine — DRUG
    Single oral dose 10 mg
  • Placebo — DRUG
    sugar pill

Study Details

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.

Key Dates

Start date
Sep 30, 2016
Status verified
Dec 2024
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Autonomic Dysfunction Center/ Vanderbilt University Medical CenterNashvilleTennessee37232
Emily C Smith, RN
[email protected]
615.875.1516
Bonnie K Black, RN
[email protected]
615-322-3304
Bonnie K Black, RN (SUB_INVESTIGATOR)
Luis E Okamoto, MD (SUB_INVESTIGATOR)
Italo Biaggioni, MD (PRINCIPAL_INVESTIGATOR)
Alfredo Gamboa, MD (SUB_INVESTIGATOR)
Cyndya A Shibao, MD (SUB_INVESTIGATOR)
Andre Diedrich, MD, PhD (SUB_INVESTIGATOR)

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Autonomic Dysfunction Center/ Vanderbilt University Medical Center· Nashville, TN

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