A Dose Titration of Droxidopa in Patients With Spinal Cord Injury
Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
Summary
The investigators seek to determine the efficacy, duration of action and safety of escalating
dose of droxidopa on systemic blood pressure, cerebral blood flow and vasoactive hormones and
catecholamines during upright seated posture.
Primary Question:
1. What is the lowest dose of droxidopa that increases seated SBP to 115±5 mmHg in men and
105±5 mmHg in women?
- When does the defined increase in SBP occur after oral ingestion of droxidopa?
- How long does this dose of droxidopa sustain SBP at these levels?
- What are the vital signs and the subjective symptomology following droxidopa
administration?
Secondary Question:
1. What is the MFV response to droxidopa administration in hypotensive individuals with SCI?
- Does an increase in SBP correspond to an increase in MCA MFV?
Tertiary Question:
1. What is the vasoactive hormone and catecholamine response to droxidopa administration in
hypotensive individuals with SCI?
- Does droxidopa administration result in a change in APR, Aldo or NE in hypotensive
individuals with SCI?