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Alpha-1 Agonist

Midodrine for Orthostatic Intolerance in Parkinson's Disease

N/A
Waitlist Available
Led By James Morley, DOMD/Ph.D.
Research Sponsored by Corporal Michael J. Crescenz VA Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a diagnosis of idiopathic Parkinson's Disease
Be older than 18 years old
Must not have
Patients on phenylephrine, pseudoephedrine, ephedrine, phenylpropanolamine, dihydroergotamine
Diagnosis of degenerative parkinsonian syndromes other than idiopathic Parkinson's Disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 weeks
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial will test whether the drug midodrine can reduce feelings of lightheadedness in patients with or without orthostatic hypotension (low blood pressure when standing up). It will also look at the drug's effect on blood pressure and heart rate during a physical test, and how this relates to symptom improvement.

Who is the study for?
This trial is for people with Parkinson's Disease who feel lightheaded when standing up. It includes those diagnosed with idiopathic Parkinson's and either have orthostatic hypotension or symptoms of it without the low blood pressure readings. Participants must be able to stand independently for 5 minutes, not be pregnant or breastfeeding, use effective contraception if applicable, and not have certain health conditions like severe heart issues or renal failure.
What is being tested?
The study tests whether Midodrine can help reduce feelings of lightheadedness in Parkinson's patients when they stand up. The drug’s effect on blood pressure and heart rate during a Valsalva maneuver (a breathing technique) will also be measured to see if there’s any improvement in symptoms.
What are the potential side effects?
Midodrine may cause side effects such as tingling scalp sensation, chills, goosebumps, stomach pain, trouble urinating due to its action on increasing blood pressure. Since it affects the cardiovascular system directly, monitoring for adverse reactions related to heart rate and rhythm is necessary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Parkinson's Disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking medications like phenylephrine or ephedrine.
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My condition is a parkinsonian syndrome that is not Parkinson's Disease.
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I have difficulty understanding or making decisions due to cognitive issues.
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My kidney function is impaired (GFR <60).
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I cannot stand by myself or stay standing for 5 minutes.
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I am currently taking medication for low blood pressure when standing.
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My blood pressure is over 139/90 and my heart rate is below 60.
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I have a history of severe heart issues, diabetes, glaucoma, arrhythmias, or difficulty urinating.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
NMSS Domain I (improvement in symptoms of lightheadedness when standing)
Secondary study objectives
Valsalva response (Beat-to-beat blood pressure and heart rate variation during Valsalva maneuver)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: MidodrineActive Control1 Intervention
Midodrine 2.5 mg given three times a day for one week followed by 5 mg given three times a day for one week
Group II: PlaceboPlacebo Group1 Intervention
Placebo given three times a day for 2 weeks

Find a Location

Who is running the clinical trial?

Corporal Michael J. Crescenz VA Medical CenterLead Sponsor
30 Previous Clinical Trials
9,997 Total Patients Enrolled
James Morley, DOMD/Ph.D.Principal InvestigatorPVAMC

Media Library

Midodrine (Alpha-1 Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT02365012 — N/A
Orthostatic Intolerance Research Study Groups: Placebo, Midodrine
Orthostatic Intolerance Clinical Trial 2023: Midodrine Highlights & Side Effects. Trial Name: NCT02365012 — N/A
Midodrine (Alpha-1 Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02365012 — N/A
~4 spots leftby Nov 2025
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