Status:
RECRUITING
Spinal Cord Injury Neuroprotection With Glyburide
Lead Sponsor:
University of Kentucky
Conditions:
Acute Spinal Cord Injury
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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.
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 in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05426681
Start Date
July 7 2022
End Date
May 1 2028
Last Update
October 24 2025
Active Locations (1)
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1
University of Kentucky
Lexington, Kentucky, United States, 40536