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