Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
25 participants
INTERVENTIONAL
2023-07-01
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Study 1
Twenty-five participants will be asked to visit the laboratory on 6 occasions, for an open-label, dose escalation trial to determine the effect of midodrine and droxidopa on supine and seated blood pressure and on symptoms of autonomic dysreflexia and orthostatic hypotension.
Midodrine Hydrochloride
Determine best drug and dose to increase and stabilize SBP during orthostatic tilt
Study 2
Determine the effects of compression garments, midodrine, and droxidopa, compared to placebo, on orthostatic hemodynamics, symptoms of AD and OH and reporting of fatigue and thermal comfort.
Midodrine Hydrochloride
Determine best drug and dose to increase and stabilize SBP during orthostatic tilt
Interventions
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Midodrine Hydrochloride
Determine best drug and dose to increase and stabilize SBP during orthostatic tilt
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* at least 12 months post injury
* injury level of C1-T6
* AIS A, B or C
* non-ambulatory
* non-ventilator
Exclusion Criteria
* Stroke or cerebrovascular disease
* Alzheimer's Disease or dementia
* Unmanaged cardiac arrhythmias
* Concurrent systemic, hepatic, or renal disease
* Suspected or diagnosed malignancy
* Neurological disease other than SCI
* Self-reported history of three or more symptomatic episodes of AD per day
18 Years
60 Years
ALL
No
Sponsors
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Kessler Foundation
OTHER
James J. Peters Veterans Affairs Medical Center
FED
Responsible Party
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Jill M. Wecht, Ed.D.
Research Scientist
Locations
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Kessler Foundation
West Orange, New Jersey, United States
James J Peters VA Medical Center
The Bronx, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1747301-1
Identifier Type: -
Identifier Source: org_study_id
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