Recruiting

Midodrine

Sponsor:

Corporal Michael J. Crescenz VA Medical Center

Code:

NCT02365012

Conditions

Orthostatic Intolerance

Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Accepted

Interventions

Midodrine

Study Details

Brief summary:

This study will evaluate whether treatment with the α1-agonist, midodrine, reduces subjective orthostatic lightheadedness as measured by the Non-Motor Symptoms Scale for Parkinson's Disease (NMSS) questionnaire, in patients with (positive control group, OH) or without documented orthostatic hypotension(orthostatic intolerance, OI). It will also demonstrate the effect of treatment with an α1-agonist, midodrine, on beat-to-beat blood pressure and heart rate response during Valsalva maneuver (measured by Continuous Non-invasive Arterial Pressure, CNAP) in patients with OI or OH and evaluate the relationship to symptom improvement.

Conditions

Orthostatic Intolerance

Parkinson's Disease

Study ID

NCT02365012

Start date

Apr, 2014

Status verified date

Aug, 2015

Primary completion date

Jun, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Patients with a diagnosis of idiopathic Parkinson's Disease
2. Those patients with measured orthostatic hypotension will be included in the positive control group
3. Those patients without measurable orthostatic hypotension who have symptoms of lightheadedness on standing will be included in the study group

Exclusion Criteria:

1. Diagnosis of degenerative parkinsonian syndromes other than idiopathic Parkinson's Disease
2. Inability to stand independently and remain standing for 5 minutes
3. Cognitive impairment that is significant enough to affect the ability of the patient to provide informed consent or to reliably report orthostatic symptoms
4. Patients with a pacemaker will also be excluded because the study is measuring heart rate responses which could potentially be altered by a pacemaker
5. Because this study will be using a drug that can affect blood pressure, those patients with a standing BP of > 139/90 and heart rate <60 will be excluded
6. Because this study will be using a drug that can affect supine hypertension, those patients with a supine BP of >139/90 and heart rate <60 will be excluded
7. Current treatment with other drugs for orthostatic hypotension such as fludrocortisone
8. Patients on phenylephrine, pseudoephedrine, ephedrine, phenylpropanolamine, dihydroergotamine
9. Patients with acute or chronic renal failure (GFR <60)
10. Patients with a history of pheochromocytoma, urinary retention, severe cardiac disease, history of congestive heart failure, diabetes, narrow-angle glaucoma, arrhythmias, bradycardia, severe hyperthyroidism, severe difficult urination (due to urinary retention or enlarged prostate)
11. Pregnant or breast-feeding women.
12. Women of childbearing potential with no effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy.
13. Women of childbearing potential must have a confirmed negative pregnancy test at screening and randomization visits. They must use an effective contraceptive method throughout the study, and agree to repeat urine pregnancy test at designated visits. The applied methods of contraception have to meet the criteria for a highly effective method of birth control (condoms, FDA approved oral contraceptives, patches, injections, rings, IUD).
14. Patients with known drug allergy or hypersensitive to midodrine.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Placebo given three times a day for 2 weeks

active comparator: Midodrine

Midodrine 2.5 mg given three times a day for one week followed by 5 mg given three times a day for one week

Interventions

Midodrine

Crossover intervention comparing midodrine to placebo for subjects with orthostatic intolerance

Primary outcome measure

  • NMSS Domain I (improvement in symptoms of lightheadedness when standing) [ Time Frame: 7 weeks ]

Central Contacts and Locations

Central contacts

James Morley, MD/Ph.D.

215-823-5934

Stephanie Wood

215-823-5934

Locations

PVAMC

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

James Morley, MD/Ph.D.

215-823-5934

More Information

Sponsor

Corporal Michael J. Crescenz VA Medical Center

Last update posted

Aug 26, 2015

Last verified

Aug, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Corporal Michael J. Crescenz VA Medical Center on 2015-08-26.