Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02307526 · ClinicalTrials.gov registry record · Phase 2
Acetylcholinesterase Inhibition and Orthostatic Hypotension in SCI
A Phase 2 study, sponsored by James J. Peters Veterans Affairs Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT02307526 is a Phase 2 study that has completed, run by James J. Peters Veterans Affairs Medical Center. The registered enrollment target is 10 participants.
The verdict
NCT02307526, a Phase 2 study, has completed, sponsored by James J. Peters Veterans Affairs Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
Due to de-centralized cardiovascular control, persons with spinal cord injury (SCI) experience blood pressure (BP) dysregulation which manifests in chronic hypotension with exacerbation during orthostatic positioning. Although many individuals with SCI remain asymptomatic to hypotension and orthostatic hypotension (OH), we recently reported reduced memory and marginally reduced attention and processing speed in hypotensive individuals with SCI compared to a normotensive cohort. Thus, we believe that treatment of overtly asymptomatic hypotension and OH in the SCI population is clinically warranted. Currently the FDA has approved only midodrine hydrochloride for the treatment of dizziness associated with OH and proof of efficacy is limited. Acetylcholinesterase inhibition for treatment of OH is a novel concept and has gained recent recognition in models of neurogenic OH (multiple system atrophy; pure autonomic failure, diabetic neuropathy). The physiological rationale of this concept is unique: acetylcholine (AcH) is the pre-ganglionic neurotransmitter of the sympathetic nervous system. Inhibition of acetylcholinesterase will limit the breakdown of AcH thereby facilitating vascular adrenergic tone and peripheral vasoconstriction. Acetylcholinesterase inhibition has been reported to be efficacious in models of both pre-ganglionic (multiple system atrophy) and post-ganglionic (pure autonomic failure, diabetic neuropathy) origin and persons with SCI reflect a model of a preganglionic disorder. In theory, if an individual has a complete autonomic lesion, acetylcholinesterase inhibition would not be expected to improve orthostatic BP because little/no neural traffic would be transmitted to the pre-synapse. However, individuals with an incomplete autonomic lesion may benefit from this class of agent. Researchers are currently investigating the orthostatic BP effects of acetylcholinesterase inhibition with pyridostigmine bromide (60 mg) in 10 individuals with SCI.
Interventions
- DRUG Pyridostigmine Bromide
- DEVICE Tilt table test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2011-01 |
| Est. Completion | 2015-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02307526
The ClinicalTrials.gov registry entry for NCT02307526 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is James J. Peters Veterans Affairs Medical Center, which has 39 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pyridostigmine Bromide is the first listed.
NCT02307526 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02307526 about?
NCT02307526 is a clinical study titled "Acetylcholinesterase Inhibition and Orthostatic Hypotension in SCI". Due to de-centralized cardiovascular control, persons with spinal cord injury (SCI) experience blood pressure (BP) dysregulation which manifests in chronic hypotension with exacerbation during orthostatic positioning. Although many individuals with SCI remain asymptomatic to hypotension and orthosta...
What is the current status of trial NCT02307526?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2011-01. Estimated completion is 2015-03.
What interventions are being tested in trial NCT02307526?
The interventions under investigation include: Pyridostigmine Bromide (DRUG), Tilt table test (DEVICE).
Who is sponsoring clinical trial NCT02307526?
This trial is sponsored by James J. Peters Veterans Affairs Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.