Your session is about to expire
← Back to Search
Alpha-1 Agonist
Midodrine for Low Blood Pressure (SCI Trial)
Phase 4
Recruiting
Research Sponsored by James J. Peters Veterans Affairs Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial aims to understand how different treatments for low blood pressure, both non-drug and drug-based, affect the body's responses to changing positions, symptoms of autonomic dysreflexia and orth
Who is the study for?
This trial is for individuals with a spinal cord injury (SCI) that happened at least a year ago, affecting the C1-T6 regions of the spine. Participants must be non-ambulatory and have an AIS grade A, B, or C, indicating varying levels of impairment.
What is being tested?
The study is testing Midodrine Hydrochloride to see how it affects blood pressure regulation in people with SCI who experience low blood pressure when they stand up (orthostatic hypotension).
What are the potential side effects?
Midodrine may cause side effects like tingling scalp sensations, goosebumps, nausea, digestive issues or urinary problems. It can also potentially increase blood pressure too much.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Systolic blood pressure
Secondary study objectives
Cerebral blood flow velocity
Symptoms of autonomic dysreflexia and orthostatic hypotension
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Study 2Experimental Treatment1 Intervention
Determine the effects of compression garments, midodrine, and droxidopa, compared to placebo, on orthostatic hemodynamics, symptoms of AD and OH and reporting of fatigue and thermal comfort.
Group II: Study 1Experimental Treatment1 Intervention
Twenty-five participants will be asked to visit the laboratory on 6 occasions, for an open-label, dose escalation trial to determine the effect of midodrine and droxidopa on supine and seated blood pressure and on symptoms of autonomic dysreflexia and orthostatic hypotension.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midodrine Hydrochloride
2007
Completed Phase 3
~150
Find a Location
Who is running the clinical trial?
James J. Peters Veterans Affairs Medical CenterLead Sponsor
57 Previous Clinical Trials
2,855 Total Patients Enrolled
Kessler FoundationOTHER
184 Previous Clinical Trials
11,244 Total Patients Enrolled