Spinal Cord Injury Neuroprotection With Glyburide (SCING): Pilot Study: An Open-Label Prospective Evaluation of the Feasibility, Safety, Pharmacokinetics, and Preliminary Efficacy of Oral Glyburide (DiaBeta) in Patients With Acute Traumatic Spinal Cord Injury
Francis Farhadi
Summary
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.
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 st…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- 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…
Interventions
- DrugGlyBURIDE 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
Location
- University of KentuckyLexington, Kentucky