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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
Patients with measured orthostatic hypotension will be included in the positive control group
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
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I have been diagnosed with a drop in blood pressure when standing.
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I feel lightheaded when I stand up but don't have low blood pressure.

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

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

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
10,466 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

Frequently Asked Questions

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

Do patients over the age of 75 years old meet the eligibility criteria for this research project?

"In order to participate in this trial, patients must be between 22 and 89 years of age. For perspective, there are 33 clinical trials for patients under 18 and 521 for patients over 65."

Answered by AI

Who would be a qualified candidate for this research?

"This study is only looking for 50 patients that have orthostatic intolerance and are between the ages of 22 and 89."

Answered by AI

How many people are receiving the experimental treatment?

"Unfortunately, this study is no longer looking for participants. It was initially posted on April 1st, 2014 but hasn't been updated in over 5 years. However, there are 519 other trials concerning orthostatic intolerance and 13 studies regarding Midodrine that are still taking patients."

Answered by AI
~5 spots leftby Mar 2025