Spinal Cord Injury Neuroprotection With Glyburide

Purpose

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.

Condition

  • Acute Spinal Cord Injury

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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 - Any condition likely to result in the patient's death within the next 12 months - Severe renal disorder from the patient's history (e.g. dialysis) or baseline eGFR of < 30 mL/min/1.73 m2 - Known severe liver disease, or ALT > 3 times upper limit of normal or bilirubin - Blood glucose <55 mg/dL at enrollment or immediately prior to administration of DiaBeta, or a clinically significant history of hypoglycemia - Acute ST elevation myocardial infarction, and/or acute decompensated heart failure, and/or QTc > 520 ms, and/or known history of cardiac arrest (PEA, VT, VF, asystole), and/or admission for an acute coronary syndrome, myocardial infarction, or coronary intervention (percutaneous coronary intervention or coronary artery surgery) within the past 3 months - Known G6PD enzyme deficiency

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Glyburide treatment arm
  • Drug: GlyBURIDE Oral Tablet
    Enrolled 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
    Other names:
    • Diabeta

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536
Contact:
Francis Farhadi, MD, PhD
859-562-0247
francis.farhadi@uky.edu

More Details

NCT ID
NCT05426681
Status
Recruiting
Sponsor
University of Kentucky

Study Contact

H. Francis Farhadi, MD, PhD
859-323-5661
francis.farhadi@uky.edu

Detailed Description

This study will include subjects between 18 and 80 years who have experienced acute traumatic cervical or thoracic spinal cord injury. Subjects will begin an oral drug regimen of Glyburide with the initial dose being within 8 hours of the injury and again every 6 hours after for 72 total hours of treatment. The daily dose of 3.125mg on day one and 2.5 mg on days 2 and 3 will be used to determine if the investigational drug provides any neuroprotection when given soon after injury. If indicated, the subject will also have surgical intervention for spinal cord decompression surgery and spinal stabilization. Participants will have labs drawn regularly, and ECGs done throughout their hospital stay. Adverse events will be monitored daily through day 14 of participation or hospital discharge (whichever is earlier). Study participation will last for 365 days (+/- 30 days), with post-hospitalization follow-up occurring on days 28, 42, 84, 182, and 365.