Midodrine for Fainting

(POST 4 Trial)

Recruiting at 16 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Dr. Bob Sheldon

Disqualifiers: Hypertension, Seizure disorder, Hepatic disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

134 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests whether Midodrine can prevent frequent fainting in adults by increasing blood pressure through tightening blood vessels. Midodrine has been shown to be effective in treating low blood pressure in various populations, including those with nervous system issues and spinal cord injuries.

Eligibility Criteria

This trial is for adults who have fainted at least twice in the past year and score ≥ -2 on a specific fainting symptom scale. They must be over 18, able to consent, and not have other causes of fainting like heart issues or seizures, nor conditions like urinary retention, liver disease, glaucoma, or uncontrolled high blood pressure.

Inclusion Criteria

You have fainted two or more times in the year before joining the study.

You have a syncope symptom score of -2 or higher for structurally normal hearts.

Exclusion Criteria

You have medical conditions that can cause fainting, like heart rhythm problems or low blood pressure when standing up.

You have trouble peeing.

Patients with an inability to give informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either midodrine hydrochloride or a placebo to test its effectiveness in preventing vasovagal syncope

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Matching Placebo
• Midodrine Hydrochloride

Trial Overview The study is testing if Midodrine can prevent fainting in people with frequent vasovagal syncope (a common cause of fainting). Participants will either receive Midodrine or a placebo without knowing which one they're getting to compare the effects fairly.

Participant Groups

Group I: midodrine hydrochloride pills Active Control 1 Intervention

Group II: oral placebo or sugar pill Placebo Group 2 Interventions

Midodrine Hydrochloride is already approved in United States, European Union, Canada for the following indications:

Approved in United States as ProAmatine for:

• Orthostatic hypotension

Approved in European Union as Orvaten for:

• Orthostatic hypotension

Approved in Canada as Midodrine Hydrochloride for:

• Orthostatic hypotension

Who Is Running the Clinical Trial?

Dr. Bob Sheldon

Lead Sponsor

Trials

1

Recruited

130+

Vanderbilt University

Collaborator

Trials

714

Recruited

6,143,000+