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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 min of head up tilt

Awards & highlights

Study 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.Check my eligibility

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).See study design

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

Select...

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Stroke volume

Side effects data

From 2018 Phase 4 trial • 15 Patients • NCT03115827

13%

Nausea

Palpitations

Influenza-like symptoms

Conjunctival Hemhorrage

Increased Uncoordinated Movements

transient cholecystitis

Brief Confusional Episode

Increased Foot Dystonia

ventral hernia

Increased Freezing

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

Placebo

1995

Completed Phase 3

~2670

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

856 Previous Clinical Trials

672,158 Total Patients Enrolled

8 Trials studying Autonomic Failure

255 Patients Enrolled for Autonomic Failure

Italo Biaggioni, MDPrincipal Investigator - Vanderbilt University Medical Center

Vanderbilt University Medical Center

28 Previous Clinical Trials

1,420 Total Patients Enrolled

9 Trials studying Autonomic Failure

635 Patients Enrolled for Autonomic Failure

Media Library

Droxidopa (Vasopressor) Clinical Trial Eligibility Overview. Trial Name: NCT02897063 — Phase 1

Autonomic Failure Research Study Groups: Midodrine and Placebo, Droxidopa and Placebo

Autonomic Failure Clinical Trial 2023: Droxidopa Highlights & Side Effects. Trial Name: NCT02897063 — Phase 1

Droxidopa (Vasopressor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02897063 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are senior citizens aged eighty or above able to participate in this study?

"To meet the requirements of this trial, applicants must be between 40 and 80 years old. By contrast, there are 76 trials for minors and 706 studies dedicated to seniors."

Answered by AI

What is the capacity of participants accepted into this trial?

"Affirmative. Information available on clinicaltrials.gov verifies that this research is still accepting participants, with the original posting dating back to September 1st 2016 and an update occurring on June 8th 2022. 34 individuals need to be recruited through a single medical centre for this study to move forward."

Answered by AI

Have any additional experiments been conducted involving Droxidopa?

"Currently, 14 studies are being conducted to assess the efficacy of Droxidopa. One is in its final phase, while most of the clinical trials take place in Nashville, Tennessee; however 29 other locations have also been identified for testing."

Answered by AI

For what clinical indications is Droxidopa commonly prescribed?

"Droxidopa is a medication that has been shown to effectively treat hypotension and orthostatic conditions, such as Parkinson's disease (PD), non-diabetic autonomic neuropathy, and dopamine-beta-monooxygenase."

Answered by AI

Are there any vacancies for potential participants in this research?

"According to clinicaltrials.gov, this experiment is open for recruitment and has been since the initial posting on September 1st 2016 with its most recent update occurring on June 8th 2022."

Answered by AI

Has the FDA sanctioned Droxidopa for clinical use?

"Our team evaluated Droxidopa's safety on a scale of 1 to 3, and assigned it a score of 1 due its Phase 1 status – meaning only preliminary data exists in regards to efficacy and protection."

Answered by AI

Who would be considered a prime candidate for participation in this experiment?

"This clinical trial is in need of 34 participants, aged between 40 and 80 years old, with orthostatic hypotension. To be eligible for enrollment one must satisfy the following: Male or female adults within the designated age range; Possible or probable Multiple System Atrophy (MSA), Pure Autonomic Failure (PAF) or Parkinson disease as per Consensus Criteria; Neurogenic Orthostatic Hypotension - a reduction of 30 mmHg systolic blood pressure 3 minutes after standing accompanied by impaired autonomic reflexes absent other causes; Openness to provide voluntary informed consent."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure

Italo Biaggioni 2016. "Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02897063.

All > Multiple System Atrophy > Parkinson Disease