Phase 4 N=21 Randomized Double-blind Treatment

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

Hypotension, Orthostatic · Hypotension · Spinal Cord Injuries

Bottom Line

View on ClinicalTrials.gov: NCT03602014 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcome: Primary: Proportion of Systolic BP Within a Normotensive Range — 167; 117; 89 Systolic Blood Pressure Recordings

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Northera (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: James J. Peters Veterans Affairs Medical Center
Primary completion: Dec 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Systolic BP Within a Normotensive Range	167; 117; 89	—
SECONDARY Supine Systolic Blood Pressure	99.9; 110.9; 107.9	—
SECONDARY Orthostatic Systolic Blood Pressure	99.92; 91.99	—
SECONDARY Orthostatic Cerebral Blood Flow	36.4; 36.8	—

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.

Eligibility Criteria

Inclusion Criteria

Study 1:

Male or Female, age 18 to 89 with traumatic SCI.
SCI Subjects (n=40):
Any level of injury;
Any American Spinal Injury Association Impairment Scale (AIS) grade of SCI;
Non-ventilator dependent
Primarily wheelchair dependent for mobility;
Duration of injury < 1 year
Low Blood Pressure:
Systolic BP less than 110 mmHg and/or diastolic BP less than 70 mmHg for males.
Systolic BP less than 100 mmHg and/or diastolic BP less than 70 mmHg for females.
Primary Language is English.
Able to provide informed consent

Study 2:

Male or Female, age 18 to 89 with traumatic SCI.
SCI Subjects (n=40):
Any level of injury;
Any AIS grade of SCI;
Non-ventilator dependent
Primarily wheelchair dependent for mobility
Duration of injury < 1 year
Low Blood Pressure:
Systolic BP less than 110 mmHg and/or diastolic BP less than 70 mmHg for males.
Systolic BP less than 100 mmHg and/or diastolic BP less than 70 mmHg for females.
Primary Language is English.
Able to provide informed consent
Showed a normotensive blood pressure in response to Droxidopa during study 1.

Exclusion Criteria

Current illness or infection
Individuals with frequent or severe autonomic dysreflexia:
More than 3 symptomatic events per week
BP ≥140/90 mmHg
Significant adverse subjective symptoms reporting
Hypertension
Any neurological condition other than SCI (Alzheimer's disease, dementia, stroke, multiple sclerosis, Parkinson's disease, etc.)
History of epilepsy or other seizure disorder
History of traumatic brain injury (TBI)
Liver or kidney disease
Bladder problems including blockage of the urine and/or weak urine stream.
Diagnosis of a psychiatric disorder such as schizophrenia or bipolar disorder
Known artery disease, heart failure, Atrio-ventricular block, and irregular heartbeat
Any allergies to droxidopa, asprin, polyethylene oxide, polyethylene glycol, hydroxypropyl cellulose, butylated hydroxytoluene, magnesium stearate, hypromellose, yellow ferric oxide, and red ferric oxide
Major surgery in the last 30 days
Illicit drug abuse in the past 6 months
Pregnant
Your prescription medications will be reviewed by the study investigators and research staff. If you are currently taking medications to treat any of the following please make the investigators aware:

d. Depression, Schizophrenia, Attention Deficit Hyperactivity Disorder (ADHD) e. Pain (opioids) f. Infection or illness (antibiotics) g. Erectile dysfunction (Viagra, Cialis, etc.) h. Overactive bladder i. High or low blood pressure j. Migraine headaches k. Malaria l. asthma

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03602014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.