Spinal Cord Injury Neuroprotection With Glyburide
ConditionAcute Spinal Cord Injury
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFrancis Farhadi
About this trial
To assess the safety and efficacy of using oral Glyburide (Diabeta) as a neuroprotective agent in patients with acute cervical or thoracic traumatic spinal cord injury.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
No life threatening injuries resulting from the traumatic accident
No evidence of sepsis
Acute cervical or thoracic SCI with ASIA Impairment Scale Grade A, B, or C od admission.
Non-penetrating SCI at neurologic level from C2 to C8 or T1 to T12
Disqualifiers
Unconsciousness or other mental impairment that prevents neurological assessment within the first 8 hours
Acute SCI with ASIA Impairment Scale grade D or E
Currently involved in another non-observational SCI research study or receiving another investigational drug
History of hypersensitivity to sulfonylureas, in particular glyburide, or any of its components
Trial design
Design model
Single group
Treatments tested in this trial
GlyBURIDE Oral Tablet
DrugEnrolled patients will receive 12 doses of Glyburide starting within 8 hours of spinal cord injury. The dosing regimen involves an initial dose of 1.25mg followed by 11 consecutive doses of 0.625 mg every 6 hours. The total daily dose of Glyburide on Day 1, Day 2, and Day 3 will be 3.125 mg, 2.5 mg, and 2.5 mg respectively. Intervention: Drug: Glyburide
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Glyburide treatment armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of recruitment of patients with tSCI within the specified time window.
A measure of feasibility of undertaking a large phase II study among this population of patients where treatment must begin within a short injury-to-drug time window.
Time frame
within 8 hours of tSCI2
Number of drug related adverse events.
A measure of safety of treating patients with traumatic spinal cord injury with Glyburide administered orally.
Time frame
One year post treatmentSecondary outcomes
1
Neurologic recovery following tSCI
Neurologic status be assessed using the American Spinal Injury Association Impairment Scale. This neurological exam assesses sensory and motor impairments using touch and pin prick evaluations in each dermatome and muscle strength. Right and left body sides are evaluated independently. Lower the scores indicate greater degree of impairment. Touch and pin prick perception is scored using a 0-2 and NT grade. Where 0= Absent, 1= hypo/hypersensitivity, 2= normal sensation, and NT= not testable. Scores for each body side are added together and summed for a total sensation score. Maximum score possible for this section is 112 per side. Muscle function is rated on a 0-5 scale. Where 0= total paralysis, 1= palpable/visible contraction, 2= active movement, full ROM with gravity eliminated, 3= active movement, full ROM against gravity, 4= active movement, full ROM with moderate resistance, 5= Normal movement and strength, and NT= not tested. Maximum score for this section is 50 per side.
Time frame
One year post enrollment.2
Serum Pharmacokinetics to measure Glyburide concentrations.
Plasma concentrations of Glyburide will be serially quantified through day 3 following tSCI to evaluate the pharmacokinetics of the investigational drug. Comparisons will be made to reported levels achieved in healthy patient cohorts.
Time frame
Enrollment through post-treatment day 7.3
Biomarker Analysis
Standard enzyme-linked immunosorbent assay (ELISA) techniques will be used to measure blood levels of neurofilament light chain, neuron- specific enolase, tau, S100b, and glial fibrillary acidic protein levels on admission, at 24 hours and on days 3 and 7 following tSCI to evaluate serum biomarker levels. Comparisons will be made to previously published values observed in non-treated control patients
Time frame
Enrollment, Day 3, and Day 7Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Francis Farhadi
Lead sponsor
University of Kentucky
Sponsor institution
Source ClinicalTrials.gov