A Dose Titration of Droxidopa in Patients With Spinal Cord Injury

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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?

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bronx VA Medical Center
• Collaborator: Chelsea Therapeutics
• Treatments: Droxidopa

Criteria

Inclusion Criteria:

• between the ages of 18 and 65,

• diagnosed with hypotension as defined above,

• able to provide informed consent

Exclusion Criteria:

• Known or suspected sensitivity to study medication or any of its ingredients,

• current smoker,

• known coronary heart and/or artery disease,

• hypertension,

• diabetes mellitus or insipidus,

• thyroid disease,

• closed angle glaucoma,

• acute illness,

• major surgery in the last 30 days,

• renal diseases,

• pregnancy,

• recent history (within the past year) of cocaine use,

• tricyclic antidepressants, monoamine oxidase inhibitors, and catechol-O-methyltransferase inhibitors,

• currently taking vasoconstricting medicines, such as Midodrine, ephedrine, dihydroergotamine, and the triptan class of migraine drugs,

• Use of a halogen based anesthetic such as Halothane in the past 12 hours

• Currently taking Isoproterenol and other catecholamine preparations

• Peripheral Arterial Disease,

• Abdominal Aortic Aneurysm,

• Cerebrovascular Disease (Including prior CVA or TIA),

• History of or active Congestive Heart Failure,

• Known Systolic Dysfunction