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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: ClinicalTrials.gov
Last refreshed on: 7 September 2015
Main ID:  NCT02365012
Date of registration: 10/02/2015
Prospective Registration: No
Primary sponsor: Philadelphia Veterans Affairs Medical Center
Public title: Treatment of Orthostatic Intolerance in Patients With Parkinson's Disease Using Midodrine
Scientific title: Treatment of Orthostatic Intolerance in Patients With Parkinson's Disease Using Midodrine
Date of first enrolment: April 2014
Target sample size: 50
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02365012
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     James Morley, MD/Ph.D.
Address: 
Telephone: 215-823-5934
Email:
Affiliation: 
Name:     James Morley, MD/Ph.D.
Address: 
Telephone: 215-823-5934
Email:
Affiliation: 
Name:     James Morley, DOMD/Ph.D.
Address: 
Telephone:
Email:
Affiliation:  PVAMC
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Orthostatic Intolerance
Parkinson's Disease
Intervention(s)
Drug: Midodrine
Primary Outcome(s)
NMSS Domain I (improvement in symptoms of lightheadedness when standing) [Time Frame: 7 weeks]
Secondary Outcome(s)
Valsalva response (Beat-to-beat blood pressure and heart rate variation during Valsalva maneuver) [Time Frame: 7 weeks]
Secondary ID(s)
01482
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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