Treatment of Orthostatic Intolerance in Patients With Parkinson's Disease Using Midodrine
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 10, 2015
CompletedFirst Posted
Study publicly available on registry
February 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedAugust 26, 2015
August 1, 2015
3.2 years
February 10, 2015
August 25, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
NMSS Domain I (improvement in symptoms of lightheadedness when standing)
improvement in symptoms of lightheadedness when standing
7 weeks
Secondary Outcomes (1)
Valsalva response (Beat-to-beat blood pressure and heart rate variation during Valsalva maneuver)
7 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo given three times a day for 2 weeks
Midodrine
ACTIVE COMPARATORMidodrine 2.5 mg given three times a day for one week followed by 5 mg given three times a day for one week
Interventions
Crossover intervention comparing midodrine to placebo for subjects with orthostatic intolerance
Eligibility Criteria
You may qualify if:
- Patients with a diagnosis of idiopathic Parkinson's Disease
- Those patients with measured orthostatic hypotension will be included in the positive control group
- Those patients without measurable orthostatic hypotension who have symptoms of lightheadedness on standing will be included in the study group
You may not qualify if:
- Diagnosis of degenerative parkinsonian syndromes other than idiopathic Parkinson's Disease
- Inability to stand independently and remain standing for 5 minutes
- Cognitive impairment that is significant enough to affect the ability of the patient to provide informed consent or to reliably report orthostatic symptoms
- Patients with a pacemaker will also be excluded because the study is measuring heart rate responses which could potentially be altered by a pacemaker
- 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
- 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
- Current treatment with other drugs for orthostatic hypotension such as fludrocortisone
- Patients on phenylephrine, pseudoephedrine, ephedrine, phenylpropanolamine, dihydroergotamine
- Patients with acute or chronic renal failure (GFR \<60)
- 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)
- Pregnant or breast-feeding women.
- Women of childbearing potential with no effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy.
- 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).
- Patients with known drug allergy or hypersensitive to midodrine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PVAMC
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Morley, DOMD/Ph.D.
PVAMC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Administrator
Study Record Dates
First Submitted
February 10, 2015
First Posted
February 18, 2015
Study Start
April 1, 2014
Primary Completion
June 1, 2017
Last Updated
August 26, 2015
Record last verified: 2015-08