Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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7 September 2015 |
Main ID: |
NCT02365012 |
Date of registration:
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10/02/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Treatment of Orthostatic Intolerance in Patients With Parkinson's Disease Using Midodrine
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Scientific title:
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Treatment of Orthostatic Intolerance in Patients With Parkinson's Disease Using Midodrine |
Date of first enrolment:
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April 2014 |
Target sample size:
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50 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/show/NCT02365012 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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James Morley, MD/Ph.D. |
Address:
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Telephone:
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215-823-5934 |
Email:
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Affiliation:
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Name:
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James Morley, MD/Ph.D. |
Address:
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Telephone:
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215-823-5934 |
Email:
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Affiliation:
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Name:
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James Morley, DOMD/Ph.D. |
Address:
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Telephone:
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Email:
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Affiliation:
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PVAMC |
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Key inclusion & exclusion criteria
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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.
Age minimum:
22 Years
Age maximum:
89 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Orthostatic Intolerance
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Parkinson's Disease
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Intervention(s)
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Drug: Midodrine
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Primary Outcome(s)
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NMSS Domain I (improvement in symptoms of lightheadedness when standing)
[Time Frame: 7 weeks]
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Secondary Outcome(s)
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Valsalva response (Beat-to-beat blood pressure and heart rate variation during Valsalva maneuver)
[Time Frame: 7 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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