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

• Status: Recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: James J. Peters Veterans Affairs Medical Center
• Collaborator: New York State Department of Health
• Treatments: Antihypertensive Agents; Droxidopa; Norepinephrine

Criteria

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