Hypotension, OrthostaticPhase 4NCT03602014
Dose Response to the Norepinephrine Precursor Droxidopa in Hypotensive Individuals With Spinal Cord Injury
A Phase 4 study testing Northera in people with Hypotension, Orthostatic and Hypotension, run by James J. Peters Veterans Affairs Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypotension, Orthostatic, Hypotension, Spinal Cord Injuries
- What is being tested?
- Northera
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2018to 31 Dec 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 27Show fewer
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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:
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Icahn School of Medicine at Mount Sinai
New York, New York, 10029
James J. Peters Veteran's Affair Medical Center
The Bronx, New York, 10468
About this study
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.
Read the detailed description
Interruption of sympathetic cardiovascular autonomic regulation following spinal cord injury (SCI) is associated with significantly reduced plasma norepinephrine (NE) levels, hypotension and orthostatic hypotension (OH), particularly in individuals with high cord lesions. Although the incidence of hypotension is reported to be as high as 70% in persons with cervical lesions (i.e., tetraplegia), the vast majority of these individuals remains asymptomatic and, therefore, does not raise clinical concern, or prompt intervention. While it is appreciated that clinicians are faced with substantial challenges in managing blood pressure (BP) in persons with SCI, contrary to the prevailing belief, asymptomatic hypotension and OH are not benign conditions. Reports suggest that asymptomatic hypotensive individuals with SCI may have subclinical cognitive dysfunction affecting memory and attention processing and increased incidence of fatigue and depression compared to normotensive individuals with SCI. It must be appreciated that to date, there are no FDA approved pharmaceutical options proven to be safe and effective for treatment of hypotension and OH in the SCI population. Until 2014, midodrine hydrochloride was the only agent with FDA approval for treatment of symptomatic neurogenic OH (NOH). Midodrine, an alpha-agonist, is the most commonly prescribed agent used to treat symptomatic hypotension in the SCI population despite a lack of convincing evidence of safety or efficacy. In 2014 droxidopa (L-threo-3,4-dihydroxyphenylserine - NORTHERA; Chelsea Therapeutics, Charlotte, NC) was approved by the FDA for treatment of symptomatic NOH based on data collected in conditions of autonomic dysfunction. Droxidopa is a NE precursor that is stored in neuronal and non-neuronal tissue and has been shown to increase standing BP and reduce symptoms of orthostatic intolerance in individuals with symptomatic NOH. We recently reported preliminary evidence of a mean increase in seated BP in individuals with SCI following oral administration of 400 mg of droxidopa; however, this dose was effective in only 5 of the 10 subjects tested and the BP effect waned over a 4-hour observation. Because of its unique pharmacokinetic profile, droxidopa is a highly promising agent to treat hypotension in persons with SCI. As such; there exists a pressing imperative to determine the clinical value and safety of droxidopa in hypotensive individuals with SCI.
- Conditions
- Hypotension, Orthostatic, Hypotension, Spinal Cord Injuries
- Being tested
- Northera, Placebo
- Keywords
- Hypotension, Spinal Cord Injury, Droxidopa, Northera, Neurogenic Orthostatic Hypotension
- Medical subject headings
- Hypotension, Orthostatic, Hypotension, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NortheraDrug
Also called Droxidopa
Study 1 is a dose optimization, open-label trial of Northera from a dose range of 200mg up to 800mg.
PlaceboOther
Study 2 is blinded placebo controlled trial using the individualized optimal dose of droxidopa determined by study 1.
| Study group | Role | What they receive |
|---|---|---|
| Study 1: Dose Optimization of Northera | Experimental | Subjects will be administered oral droxidopa in a dose escalation, open-label manner beginning with 200 mg. The dose will be adjusted upwards by 100 mg on subsequent visits until average Systolic Blood Pressure (SBP) recorded 60-120 minutes after dose administration is 111-139 mmHg in males and 101-139 mmHg in females, sustained elevation (≥ 30 consecutive minutes) in seated SBP ≥ 140/100 mmHg, maximum dose of 800 mg is reached without adequate SBP response. Subjects will visit the testing laboratory on as few as 1 (200 mg) and as many as 7 (800 mg) days. Seated cardiovascular assessments will be monitored and recorded at 15-minute intervals for 4-hours, and the side effects questionnaire will be administered hourly during the 4-hour study. Each study visit will take about 5 hours. Receives: Drug: Northera |
| Study 2: Blinded Placebo & Northera | Placebo comparator | Participants will then be administered either oral optimal dose of Northera (Droxidopa) or matching placebo in a double-blinded manner and will remain in the supine position for 60 minutes. Subjects will remain in their wheelchair for instrumentation, which will include: 1) ECG, 2) brachial BP, 3) finger arteriolar BP and 4) Cerebral Blood Flow velocity (CBFv). Receives: Drug: Northera; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Systolic BP Within a Normotensive Range
To determine the proportion (%) of normotensive systolic blood pressure for males=(110-120 mmHg); and females=(101-120 mmHg) following administration of droxidopa.
Measured: up to 240 minutes following administration of droxidopa
Secondary outcomes (3)
Supine Systolic Blood Pressure
To measure supine systolic blood pressure following administration of droxidopa compared to placebo in hypotensive participants with SCI
Measured: within 60 minutes of administration of droxidopa or placebo
Orthostatic Systolic Blood Pressure
To document systolic blood pressure responses to head-up tilt to 70 degrees following administration of droxidopa compared to placebo in hypotensive participants with SCI.
Measured: 60-90 minutes following administration of droxidopa or placebo
Orthostatic Cerebral Blood Flow
To compare cerebral blood flow velocity in the middle cerebral artery following administration of placebo compared to administration of Northera (Droxidopa)
Measured: 60-90 minutes following administration of droxidopa or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Jun 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (119)Papers the sponsor has linked to this study.
- Other trials for Hypotension, OrthostaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- New York State Department of Health
- Responsible party
- Principal investigator, Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center
- Investigators
- Jill M Wecht, Ed.D, Principal investigator, James J. Peter's VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602014
- Sponsor's protocol ID
- WEC-17-042
- Status last verified
- Feb 2025
- First submitted
- 15 Feb 2018
- Last updated
- 7 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Claydon VE, Krassioukov AV. Orthostatic hypotension and autonomic pathways after spinal cord injury. J Neurotrauma. 2006 Dec;23(12):1713-25. doi: 10.1089/neu.2006.23.1713.
PubMed 17184183GUTTMANN L, MUNRO AF, ROBINSON R, WALSH JJ. EFFECT OF TILTING ON THE CARDIOVASCULAR RESPONSES AND PLASMA CATECHOLAMINE LEVELS IN SPINAL MAN. Paraplegia. 1963 May;1:4-18. doi: 10.1038/sc.1963.2. No abstract available.
PubMed 14087938Mathias CJ, Christensen NJ, Corbett JL, Frankel HL, Goodwin TJ, Peart WS. Plasma catecholamines, plasma renin activity and plasma aldosterone in tetraplegic man, horizontal and tilted. Clin Sci Mol Med. 1975 Oct;49(4):291-9. doi: 10.1042/cs0490291.
PubMed 1192688Wecht JM, Weir JP, Goldstein DS, Krothe-Petroff A, Spungen AM, Holmes C, Bauman WA. Direct and reflexive effects of nitric oxide synthase inhibition on blood pressure. Am J Physiol Heart Circ Physiol. 2008 Jan;294(1):H190-7. doi: 10.1152/ajpheart.00366.2007. Epub 2007 Oct 26.
PubMed 17965289Wecht JM, Zhu C, Weir JP, Yen C, Renzi C, Galea M. A prospective report on the prevalence of heart rate and blood pressure abnormalities in veterans with spinal cord injuries. J Spinal Cord Med. 2013 Sep;36(5):454-62. doi: 10.1179/2045772313Y.0000000109.
PubMed 23941793Zhu C, Galea M, Livote E, Signor D, Wecht JM. A retrospective chart review of heart rate and blood pressure abnormalities in veterans with spinal cord injury. J Spinal Cord Med. 2013 Sep;36(5):463-75. doi: 10.1179/2045772313Y.0000000145.
PubMed 23941794Jegede AB, Rosado-Rivera D, Bauman WA, Cardozo CP, Sano M, Moyer JM, Brooks M, Wecht JM. Cognitive performance in hypotensive persons with spinal cord injury. Clin Auton Res. 2010 Feb;20(1):3-9. doi: 10.1007/s10286-009-0036-z. Epub 2009 Oct 16.
PubMed 19842013Phillips AA, Krassioukov AV, Ainslie PN, Warburton DE. Perturbed and spontaneous regional cerebral blood flow responses to changes in blood pressure after high-level spinal cord injury: the effect of midodrine. J Appl Physiol (1985). 2014 Mar 15;116(6):645-53. doi: 10.1152/japplphysiol.01090.2013. Epub 2014 Jan 16.
PubMed 24436297Phillips AA, Warburton DE, Ainslie PN, Krassioukov AV. Regional neurovascular coupling and cognitive performance in those with low blood pressure secondary to high-level spinal cord injury: improved by alpha-1 agonist midodrine hydrochloride. J Cereb Blood Flow Metab. 2014 May;34(5):794-801. doi: 10.1038/jcbfm.2014.3. Epub 2014 Jan 29.
PubMed 24473484Wecht JM, Bauman WA. Decentralized cardiovascular autonomic control and cognitive deficits in persons with spinal cord injury. J Spinal Cord Med. 2013 Mar;36(2):74-81. doi: 10.1179/2045772312Y.0000000056.
PubMed 23809520Wecht JM, Rosado-Rivera D, Jegede A, Cirnigliaro CM, Jensen MA, Kirshblum S, Bauman WA. Systemic and cerebral hemodynamics during cognitive testing. Clin Auton Res. 2012 Feb;22(1):25-33. doi: 10.1007/s10286-011-0139-1. Epub 2011 Jul 27.
PubMed 21792728Krassioukov A, Eng JJ, Warburton DE, Teasell R; Spinal Cord Injury Rehabilitation Evidence Research Team. A systematic review of the management of orthostatic hypotension after spinal cord injury. Arch Phys Med Rehabil. 2009 May;90(5):876-85. doi: 10.1016/j.apmr.2009.01.009.
PubMed 19406310Kaufmann H, Freeman R, Biaggioni I, Low P, Pedder S, Hewitt LA, Mauney J, Feirtag M, Mathias CJ; NOH301 Investigators. Droxidopa for neurogenic orthostatic hypotension: a randomized, placebo-controlled, phase 3 trial. Neurology. 2014 Jul 22;83(4):328-35. doi: 10.1212/WNL.0000000000000615. Epub 2014 Jun 18.
PubMed 24944260Kaufmann H, Norcliffe-Kaufmann L, Palma JA. Droxidopa in neurogenic orthostatic hypotension. Expert Rev Cardiovasc Ther. 2015;13(8):875-91. doi: 10.1586/14779072.2015.1057504. Epub 2015 Jun 19.
PubMed 26092297Kaufmann H, Saadia D, Voustianiouk A, Goldstein DS, Holmes C, Yahr MD, Nardin R, Freeman R. Norepinephrine precursor therapy in neurogenic orthostatic hypotension. Circulation. 2003 Aug 12;108(6):724-8. doi: 10.1161/01.CIR.0000083721.49847.D7. Epub 2003 Jul 28.
PubMed 12885750
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Response to the Norepinephrine Precursor Droxidopa in Hypotensive Individuals With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03602014
- Acronym / sponsor ID
- WEC-17-042
- Conditions
- Hypotension, Orthostatic, Hypotension, Spinal Cord Injuries
- Keywords
- Hypotension, Spinal Cord Injury, Droxidopa, Northera, Neurogenic Orthostatic Hypotension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Collaborators
- New York State Department of Health
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Posted 7 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Interruption of sympathetic cardiovascular autonomic regulation following spinal cord injury (SCI) is associated with significantly reduced plasma norepinephrine (NE) levels, hypotension and orthostatic hypotension (OH), particularly in individuals with high cord lesions. Although the incidence of hypotension is reported to be as high as 70% in persons with cervical lesions (i.e., tetraplegia), the vast majority of these individuals remains asymptomatic and, therefore, does not raise clinical concern, or prompt intervention. While it is appreciated that clinicians are faced with substantial challenges in managing blood pressure (BP) in persons with SCI, contrary to the prevailing belief, asymptomatic hypotension and OH are not benign conditions. Reports suggest that asymptomatic hypotensive individuals with SCI may have subclinical cognitive dysfunction affecting memory and attention processing and increased incidence of fatigue and depression compared to normotensive individuals with SCI. It must be appreciated that to date, there are no FDA approved pharmaceutical options proven to be safe and effective for treatment of hypotension and OH in the SCI population. Until 2014, midodrine hydrochloride was the only agent with FDA approval for treatment of symptomatic neurogenic OH (NOH). Midodrine, an alpha-agonist, is the most commonly prescribed agent used to treat symptomatic hypotension in the SCI population despite a lack of convincing evidence of safety or efficacy. In 2014 droxidopa (L-threo-3,4-dihydroxyphenylserine - NORTHERA; Chelsea Therapeutics, Charlotte, NC) was approved by the FDA for treatment of symptomatic NOH based on data collected in conditions of autonomic dysfunction. Droxidopa is a NE precursor that is stored in neuronal and non-neuronal tissue and has been shown to increase standing BP and reduce symptoms of orthostatic intolerance in individuals with symptomatic NOH. We recently reported preliminary evidence of a mean increase in seated BP in individuals with SCI following oral administration of 400 mg of droxidopa; however, this dose was effective in only 5 of the 10 subjects tested and the BP effect waned over a 4-hour observation. Because of its unique pharmacokinetic profile, droxidopa is a highly promising agent to treat hypotension in persons with SCI. As such; there exists a pressing imperative to determine the clinical value and safety of droxidopa in hypotensive individuals with SCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study 1: Dose Optimization of Northera | Experimental | Drug: NortheraSubjects will be administered oral droxidopa in a dose escalation, open-label manner beginning with 200 mg. The dose will be adjusted upwards by 100 mg on subsequent visits until average Systolic Blood Pressure (SBP) recorded 60-120 minutes after dose administration is 111-139 mmHg in males and 101-139 mmHg in females, sustained elevation (≥ 30 consecutive minutes) in seated SBP ≥ 140/100 mmHg, maximum dose of 800 mg is reached without adequate SBP response. Subjects will visit the testing laboratory on as few as 1 (200 mg) and as many as 7 (800 mg) days. Seated cardiovascular assessments will be monitored and recorded at 15-minute intervals for 4-hours, and the side effects questionnaire will be administered hourly during the 4-hour study. Each study visit will take about 5 hours. |
| Study 2: Blinded Placebo & Northera | Placebo comparator | Drug: Northera, Other: PlaceboParticipants will then be administered either oral optimal dose of Northera (Droxidopa) or matching placebo in a double-blinded manner and will remain in the supine position for 60 minutes. Subjects will remain in their wheelchair for instrumentation, which will include: 1) ECG, 2) brachial BP, 3) finger arteriolar BP and 4) Cerebral Blood Flow velocity (CBFv). |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Male or Female, age 18 to 89 with traumatic SCI.
- SCI Subjects (n=40):
- Low Blood Pressure:
- Primary Language is English.
- Able to provide informed consent
Key exclusion criteria (19 listed)
- Current illness or infection
- Individuals with frequent or severe autonomic dysreflexia:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NortheraAlso: DroxidopaStudy 1 is a dose optimization, open-label trial of Northera from a dose range of 200mg up to 800mg. | Drug | Study 1: Dose Optimization of Northera, Study 2: Blinded Placebo & Northera |
| PlaceboStudy 2 is blinded placebo controlled trial using the individualized optimal dose of droxidopa determined by study 1. | Other | Study 2: Blinded Placebo & Northera |
Primary outcome
Proportion of Systolic BP Within a Normotensive Range
Time frame: up to 240 minutes following administration of droxidopa
To determine the proportion (%) of normotensive systolic blood pressure for males=(110-120 mmHg); and females=(101-120 mmHg) following administration of droxidopa.
3 secondary outcomes
Supine Systolic Blood Pressure
Time frame: within 60 minutes of administration of droxidopa or placebo
Orthostatic Systolic Blood Pressure
Time frame: 60-90 minutes following administration of droxidopa or placebo
Orthostatic Cerebral Blood Flow
Time frame: 60-90 minutes following administration of droxidopa or placebo
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17184183Claydon VE, Krassioukov AV. Orthostatic hypotension and autonomic pathways after spinal cord injury. J Neurotrauma. 2006 Dec;23(12):1713-25. doi: 10.1089/neu.2006.23.1713.
- Background: PubMed 14087938GUTTMANN L, MUNRO AF, ROBINSON R, WALSH JJ. EFFECT OF TILTING ON THE CARDIOVASCULAR RESPONSES AND PLASMA CATECHOLAMINE LEVELS IN SPINAL MAN. Paraplegia. 1963 May;1:4-18. doi: 10.1038/sc.1963.2. No abstract available.
- Background: PubMed 1192688Mathias CJ, Christensen NJ, Corbett JL, Frankel HL, Goodwin TJ, Peart WS. Plasma catecholamines, plasma renin activity and plasma aldosterone in tetraplegic man, horizontal and tilted. Clin Sci Mol Med. 1975 Oct;49(4):291-9. doi: 10.1042/cs0490291.
- Background: PubMed 17965289Wecht JM, Weir JP, Goldstein DS, Krothe-Petroff A, Spungen AM, Holmes C, Bauman WA. Direct and reflexive effects of nitric oxide synthase inhibition on blood pressure. Am J Physiol Heart Circ Physiol. 2008 Jan;294(1):H190-7. doi: 10.1152/ajpheart.00366.2007. Epub 2007 Oct 26.
- Background: PubMed 23941793Wecht JM, Zhu C, Weir JP, Yen C, Renzi C, Galea M. A prospective report on the prevalence of heart rate and blood pressure abnormalities in veterans with spinal cord injuries. J Spinal Cord Med. 2013 Sep;36(5):454-62. doi: 10.1179/2045772313Y.0000000109.
- Background: PubMed 23941794Zhu C, Galea M, Livote E, Signor D, Wecht JM. A retrospective chart review of heart rate and blood pressure abnormalities in veterans with spinal cord injury. J Spinal Cord Med. 2013 Sep;36(5):463-75. doi: 10.1179/2045772313Y.0000000145.
- Background: PubMed 19842013Jegede AB, Rosado-Rivera D, Bauman WA, Cardozo CP, Sano M, Moyer JM, Brooks M, Wecht JM. Cognitive performance in hypotensive persons with spinal cord injury. Clin Auton Res. 2010 Feb;20(1):3-9. doi: 10.1007/s10286-009-0036-z. Epub 2009 Oct 16.
- Background: PubMed 24436297Phillips AA, Krassioukov AV, Ainslie PN, Warburton DE. Perturbed and spontaneous regional cerebral blood flow responses to changes in blood pressure after high-level spinal cord injury: the effect of midodrine. J Appl Physiol (1985). 2014 Mar 15;116(6):645-53. doi: 10.1152/japplphysiol.01090.2013. Epub 2014 Jan 16.
- Background: PubMed 24473484Phillips AA, Warburton DE, Ainslie PN, Krassioukov AV. Regional neurovascular coupling and cognitive performance in those with low blood pressure secondary to high-level spinal cord injury: improved by alpha-1 agonist midodrine hydrochloride. J Cereb Blood Flow Metab. 2014 May;34(5):794-801. doi: 10.1038/jcbfm.2014.3. Epub 2014 Jan 29.
- Background: PubMed 23809520Wecht JM, Bauman WA. Decentralized cardiovascular autonomic control and cognitive deficits in persons with spinal cord injury. J Spinal Cord Med. 2013 Mar;36(2):74-81. doi: 10.1179/2045772312Y.0000000056.
- Background: PubMed 21792728Wecht JM, Rosado-Rivera D, Jegede A, Cirnigliaro CM, Jensen MA, Kirshblum S, Bauman WA. Systemic and cerebral hemodynamics during cognitive testing. Clin Auton Res. 2012 Feb;22(1):25-33. doi: 10.1007/s10286-011-0139-1. Epub 2011 Jul 27.
- Background: PubMed 19406310Krassioukov A, Eng JJ, Warburton DE, Teasell R; Spinal Cord Injury Rehabilitation Evidence Research Team. A systematic review of the management of orthostatic hypotension after spinal cord injury. Arch Phys Med Rehabil. 2009 May;90(5):876-85. doi: 10.1016/j.apmr.2009.01.009.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill M Wecht, Ed.D principal investigator
James J. Peter's VAMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Northera in people with Hypotension, Orthostatic and Hypotension, run by James J. Peters Veterans Affairs Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Systolic BP Within a Normotensive Range (time frame: up to 240 minutes following administration of droxidopa). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03602014, which also lists 119 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.