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

This is an interventional treatment trial for Hypotension, Orthostatic focused on measuring Hypotension, Spinal Cord Injury, Droxidopa, Northera, Neurogenic Orthostatic Hypotension Read More

Inclusion Criteria:

Study 1:

1. Male or Female, age 18 to 89 with traumatic SCI.

2. SCI Subjects (n=40):

   1. Any level of injury;
   2. Any American Spinal Injury Association Impairment Scale (AIS) grade of SCI;
   3. Non-ventilator dependent
   4. Primarily wheelchair dependent for mobility;
   5. Duration of injury < 1 year

3. Low Blood Pressure:

   1. Systolic BP less than 110 mmHg and/or diastolic BP less than 70 mmHg for males.
   2. Systolic BP less than 100 mmHg and/or diastolic BP less than 70 mmHg for females.
4. Primary Language is English.

5. Able to provide informed consent

   Study 2:

6. Male or Female, age 18 to 89 with traumatic SCI.

7. SCI Subjects (n=40):

   1. Any level of injury;
   2. Any AIS grade of SCI;
   3. Non-ventilator dependent
   4. Primarily wheelchair dependent for mobility
   5. Duration of injury < 1 year

8. Low Blood Pressure:

   1. Systolic BP less than 110 mmHg and/or diastolic BP less than 70 mmHg for males.
   2. Systolic BP less than 100 mmHg and/or diastolic BP less than 70 mmHg for females.
9. Primary Language is English.
10. Able to provide informed consent
11. 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:

  1. More than 3 symptomatic events per week
  2. BP ≥140/90 mmHg
  3. 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