Clinical trial
Treatment of Orthostatic Hypotension in Individuals With Spinal Cord Injury
Name
1747301-1
Description
The purpose of this study is to identify the effects of non-pharmacological and pharmacological anti-hypotensive treatment interventions on orthostatic hemodynamic responses, symptoms of autonomic dysreflexia and orthostatic hypotension, and levels of fatigue and comfort in hypotensive individuals with SCI.
Trial arms
Trial start
2023-07-01
Estimated PCD
2026-06-30
Trial end
2026-06-30
Status
Recruiting
Phase
Early phase I
Treatment
Midodrine Hydrochloride
Determine best drug and dose to increase and stabilize SBP during orthostatic tilt
Arms:
Study 1, Study 2
Other names:
Droxidopa
Size
25
Primary endpoint
Systolic blood pressure
3 years
Eligibility criteria
Inclusion Criteria:
* traumatic spinal cord injury
* at least 12 months post injury
* injury level of C1-T6
* AIS A, B or C
* non-ambulatory
* non-ventilator
Exclusion Criteria:
* Active psychiatric disorder
* 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 25, 'type': 'ESTIMATED'}}
Updated at
2024-03-01
1 organization
1 product
1 indication
Organization
James J. Peters Veterans Affairs Medical CenterProduct
Midodrine HydrochlorideIndication
Low blood pressure