HypotensionPhase 4SCINCT05839652
Treatment of Orthostatic Hypotension in SCI
A Phase 4 study testing Midodrine Hydrochloride in people with Hypotension, run by James J. Peters Veterans Affairs Medical Center at 2 sites in United States.
Trial summary
The purpose of this study is to identify the effects of non-pharmacological and pharmacological anti-hypotensive treatment interventions on orthostatic hemodynamic responses, symptoms of autonomic dysreflexia and orthostatic hypotension, and levels of fatigue and comfort in hypotensive individuals with SCI. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypotension
- What is being tested?
- Midodrine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2023to 30 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- traumatic spinal cord injury
- at least 12 months post injury
- injury level of C1-T6
- AIS A, B or C
- non-ambulatory
- non-ventilator
Who cannot join
- Active psychiatric disorder
- Stroke or cerebrovascular disease
- Alzheimer's Disease or dementia
- Unmanaged cardiac arrhythmias
- Concurrent systemic, hepatic, or renal disease
- Suspected or diagnosed malignancy
- Neurological disease other than SCI
- Self-reported history of three or more symptomatic episodes of AD per day
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
James J Peters VA Medical Center
The Bronx, New York, 10468
Dylan C Arnero, MA, 718-584-9000 ext. 5124, dylan.arnero@va.gov
Jill M Wecht, EdD
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Matthew T Maher, MS, 201-566-0291, MMaher@Kesslerfoundation.org
About this study
Official title: Treatment of Orthostatic Hypotension in Individuals With Spinal Cord Injury
The purpose of this study is to identify the effects of non-pharmacological and pharmacological anti-hypotensive treatment interventions on orthostatic hemodynamic responses, symptoms of autonomic dysreflexia and orthostatic hypotension, and levels of fatigue and comfort in hypotensive individuals with SCI.
- Conditions
- Hypotension
- Being tested
- Midodrine Hydrochloride
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midodrine HydrochlorideDrug
Also called Droxidopa
Determine best drug and dose to increase and stabilize SBP during orthostatic tilt
| Study group | Role | What they receive |
|---|---|---|
| Study 1 | Experimental | Twenty-five participants will be asked to visit the laboratory on 6 occasions, for an open-label, dose escalation trial to determine the effect of midodrine and droxidopa on supine and seated blood pressure and on symptoms of autonomic dysreflexia and orthostatic hypotension. Receives: Drug: Midodrine Hydrochloride |
| Study 2 | Experimental | Determine the effects of compression garments, midodrine, and droxidopa, compared to placebo, on orthostatic hemodynamics, symptoms of AD and OH and reporting of fatigue and thermal comfort. Receives: Drug: Midodrine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
determine differences in systolic blood pressure after midodrine, droxidopa, compression stockings and placebo
Measured: 3 years
Secondary outcomes (2)
Cerebral blood flow velocity
determine differences in cerebral blood flow velocity after midodrine, droxidopa, compression stockings and placebo
Measured: 3 years
Symptoms of autonomic dysreflexia and orthostatic hypotension
determine differences in symptoms after midodrine, droxidopa, compression stockings and placebo
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Jul 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Kessler Foundation
- Responsible party
- Principal investigator, Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839652
- Sponsor's protocol ID
- 1747301-1
- Acronym
- SCI
- Status last verified
- Aug 2026
- First submitted
- 20 Apr 2023
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Orthostatic Hypotension in Individuals With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05839652
- Acronym / sponsor ID
- SCI / 1747301-1
- Conditions
- Hypotension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Kessler Foundation
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify the effects of non-pharmacological and pharmacological anti-hypotensive treatment interventions on orthostatic hemodynamic responses, symptoms of autonomic dysreflexia and orthostatic hypotension, and levels of fatigue and comfort in hypotensive individuals with SCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study 1 | Experimental | Drug: Midodrine HydrochlorideTwenty-five participants will be asked to visit the laboratory on 6 occasions, for an open-label, dose escalation trial to determine the effect of midodrine and droxidopa on supine and seated blood pressure and on symptoms of autonomic dysreflexia and orthostatic hypotension. |
| Study 2 | Experimental | Drug: Midodrine HydrochlorideDetermine the effects of compression garments, midodrine, and droxidopa, compared to placebo, on orthostatic hemodynamics, symptoms of AD and OH and reporting of fatigue and thermal comfort. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- traumatic spinal cord injury
- at least 12 months post injury
- injury level of C1-T6
- AIS A, B or C
- non-ambulatory
Key exclusion criteria (8 listed)
- Active psychiatric disorder
- Stroke or cerebrovascular disease
- Alzheimer's Disease or dementia
- Unmanaged cardiac arrhythmias
- Concurrent systemic, hepatic, or renal disease
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 |
|---|---|---|
| Midodrine HydrochlorideAlso: DroxidopaDetermine best drug and dose to increase and stabilize SBP during orthostatic tilt | Drug | Study 1, Study 2 |
Primary outcome
Systolic blood pressure
Time frame: 3 years
determine differences in systolic blood pressure after midodrine, droxidopa, compression stockings and placebo
2 secondary outcomes
Cerebral blood flow velocity
Time frame: 3 years
Symptoms of autonomic dysreflexia and orthostatic hypotension
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- 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.
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 Midodrine Hydrochloride in people with 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matt T Maher, MS (9733243588, matthew.maher@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2026.