At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 16 enrolled

Drug / intervention

N-Nitro L-arginine-methylester (L-NAME) +1 moredrug

Likely dose

L-NAME intravenous infusion during head-up tilt procedure (specific dose not stated)AI-extracted

Key inclusion· 2

✓Age 18 to 65 years
✓Non-ambulatory chronic tetraplegia, at least 1 year after acute spinal cord injury

Key exclusion· 12

✕Central nervous system disease other than SCI (e.g., multiple sclerosis, ALS, syringomyelia, tabes dorsalis)
✕Peripheral neuropathies
✕History of surgical sympathectomy
✕Coronary heart and/or artery disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00237770

NCT00237770Phase 3Completed

Compare CT.gov

Prevention of Low Blood Pressure in Persons With Tetraplegia

US Department of Veterans Affairs·interventional·Posted Oct 12, 2005·Updated May 19, 2014

In Brief

A Phase 3 clinical trial evaluating N-Nitro L-arginine-methylester (L-NAME) and Head-up Tilt maneuver for Hypotension and Spinal Cord Injury. Completed, enrolled 16 participants across 1 site.

Detailed Summary

The aim of this investigation is to determine the blood pressure response to NOS inhibition, with L-NAME, in persons with tetraplegia compared to non-SCI control subjects and to establish if blood pressure can be increased while upright in those with tetraplegia. If blood pressure is increased with NOS inhibition in persons with tetraplegia, this would improve our treatment of the condition of low blood pressure during seated postures in individuals with tetraplegia.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHypotension, Spinal Cord Injury

CountriesUnited States

Collaborators--

Timeline

Phase 3CompletedFinished

2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJun 2003

First PostedOct 2005

Primary CompletionJun 2010

TodayJul 2026

First PostedOct 12, 2005

Enrollment StartJun 1, 2003

Primary CompletionJun 1, 2010

TodayJul 2, 2026

Enrollment to primary: 7 yearsPosted 20.7 years ago

Interventions

N-Nitro L-arginine-methylester (L-NAME)drug

A non-specific inhibitor of the nitric oxide synthase enzyme.

Head-up Tilt maneuverprocedure

Participant will be placed onto tilt table and brought to 15 degrees of head up tilt for 60 minutes (intravenous infusion time). After this time, a progressive increase to 45 degrees will be completed with a 10 degree increase every 5 minutes. Participant will remain at 45 degrees for 45 minutes or until symptom onset.