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Vasopressor

Midodrine + Droxidopa for Autonomic Failure

Phase 1

Recruiting

Led By Italo Biaggioni, MD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Medical devices implanted on the abdominal wall or abdomen that would interfere with the abdominal compression

Recent fractures or fissures of ribs, thoracic or lumbar spine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 min of head up tilt

Summary

This trial is to study the effects of two drugs used to treat low blood pressure on the veins of the abdomen in patients with autonomic failure.

Who is the study for?

This trial is for adults aged 40-80 with certain neurological conditions (Multiple System Atrophy, Pure Autonomic Failure, or Parkinson's) that cause low blood pressure when standing. Participants must have a specific drop in blood pressure and no other causes of autonomic neuropathy. They can't join if they have high resting blood pressure, are pregnant, or have had recent major surgeries among other exclusions.

What is being tested?

The study at Vanderbilt University Medical Center tests the effects of Midodrine and Droxidopa on abdominal veins in patients with autonomic failure. It involves screening and two testing days over approximately five days to see how these drugs treat orthostatic hypotension (low blood pressure upon standing).

What are the potential side effects?

Potential side effects from Midodrine may include scalp tingling, chills, goosebumps, nausea; while Droxidopa could cause headaches, dizziness, nausea. Side effects vary by individual.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 40-80 years old and may have Multiple System Atrophy, Pure Autonomic Failure, or Parkinson's.

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My blood pressure drops significantly when I stand, due to nerve issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have no medical devices in my abdomen that could affect abdominal pressure.

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I have had recent fractures in my ribs or spine.

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I have severe acid reflux.

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I have a painful hernia in my abdomen or groin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 min of head up tilt

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 min of head up tilt

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 min of head up tilt for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Stroke volume

Side effects data

From 2018 Phase 4 trial • 15 Patients • NCT03115827

13%

Nausea

Brief Confusional Episode

Influenza-like symptoms

Increased Uncoordinated Movements

Increased Foot Dystonia

transient cholecystitis

ventral hernia

Increased Freezing

Conjunctival Hemhorrage

Palpitations

Dry Mouth

100%

80%

60%

40%

20%

Study treatment Arm

Arm 1

Trial Design

2Treatment groups

Experimental Treatment

Group I: Midodrine and PlaceboExperimental Treatment2 Interventions

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.

Group II: Droxidopa and PlaceboExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Droxidopa

2008

Completed Phase 4

~1450

Midodrine

2008

Completed Phase 4

~1160