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A Dose Titration of Droxidopa in Patients With Spinal Cord Injury

NCT01354158 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2013-07-30

No results posted yet for this study

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?

Conditions

Interventions

DRUG

Droxidopa

Dose titration of placebo, 100mg, 200mg, 400mg of Droxidopa will be given to assess the effects of Droxidopa on blood pressure and cerebral blood flow.

Sponsors & Collaborators

  • Chelsea Therapeutics

    collaborator INDUSTRY

  • Bronx VA Medical Center

    lead FED

Principal Investigators

  • Jill M Wecht, EdD · James J. Peters VA Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01354158 on ClinicalTrials.gov