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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Glyburide treatment arm |
|
Recruiting Locations
UK Center for Clinical and Translational Science and nearby locations
Lexington, Kentucky 40536
More Details
- NCT ID
- NCT05426681
- Status
- Recruiting
- Sponsor
- University of Kentucky
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.