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Dose Response to the Norepinephrine Precursor Droxidopa in Hypotensive Individuals With Spinal Cord Injury

NCT03602014 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-03-07

Study results available
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Summary

The goal of this study is to determine the efficacy of the drug Droxidopa (Northera) in increasing blood pressure in subject with hypotension, low blood pressure, which is classified as blood pressure less than 110/70 in males and 100/70 in females. The first aim is to determine the proportion of subject with Spinal Cord Injury (SCI) who have a normotensive response to Droxidopa. The second is to determine the proportion of subject with SCI who express a hypertensive response to Droxidopa. A Normal blood pressure ranges from 111-139 in males and 101-139 in females and a hypertensive blood pressure is anything higher than 140 in males and females.

The study would take place in James J. Peters VA Medical Center (JJPVAMC) and The Icahn School of Medicine at Mount Sinai (ISMMS) in Manhattan, New York.

Conditions

  • Hypotension, Orthostatic
  • Hypotension
  • Spinal Cord Injuries

Interventions

DRUG

Northera

Study 1 is a dose optimization, open-label trial of Northera from a dose range of 200mg up to 800mg.

OTHER

Placebo

Study 2 is blinded placebo controlled trial using the individualized optimal dose of droxidopa determined by study 1.

Sponsors & Collaborators

  • New York State Department of Health

    collaborator OTHER_GOV

  • James J. Peters Veterans Affairs Medical Center

    lead FED

Principal Investigators

  • Jill M Wecht, Ed.D · James J. Peter's VAMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2021-12-31
Completion
2021-12-31
FDA Drug
Yes

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 NCT03602014 on ClinicalTrials.gov