Spinal Cord Injury Neuroprotection With Glyburide

• Status: Not yet recruiting
• Trial end date: 2028-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Kentucky
• Treatments: Glyburide

Criteria

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