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Alpha-1 Agonist

Study 1 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

SCI 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.Check my eligibility

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).See study design

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.

SCI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Systolic blood pressure

Secondary outcome measures

Cerebral blood flow velocity

Symptoms of autonomic dysreflexia and orthostatic hypotension

SCI 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

~170

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

James J. Peters Veterans Affairs Medical CenterLead Sponsor

57 Previous Clinical Trials

2,875 Total Patients Enrolled

Kessler FoundationOTHER

174 Previous Clinical Trials

10,713 Total Patients Enrolled

Frequently Asked Questions

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

What are the potential risks associated with Trial 1 for participants?

"Given that Study 1 is a Phase 4 trial, indicating the treatment's approval status, our team at Power rates its safety as a 3 on the scale provided."

Answered by AI

Are individuals above the age of 18 eligible to participate in this study?

"Eligible participants for this study must be between 18 and 60 years old. There are separate studies available for individuals under 18 and those over 65, amounting to a total of 8 and 101 studies respectively."

Answered by AI

Are patients currently being actively recruited for participation in this trial?

"Affirmative, the information available on clinicaltrials.gov specifies that this medical study is actively pursuing candidates. The trial was initially disclosed on July 1st, 2023 and most recently revised by February 29th, 2024. Approximately 25 individuals are being sought from two designated locations for this research endeavor."

Answered by AI

How large is the participant pool in this research endeavor?

"Indeed, as per clinicaltrials.gov data, this investigation is actively seeking volunteers. It was initially listed on July 1st, 2023 and last modified on February 29th, 2024. The aim is to enroll a total of 25 participants from two distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment of Orthostatic Hypotension in SCI

Jill M. Wecht, Ed.D. 2023. "Treatment of Orthostatic Hypotension in SCI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05839652.

All > Orthostatic Hypotension