Spinal Cord Injury Neuroprotection With Glyburide

Launched by UNIVERSITY OF KENTUCKY · Jun 20, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medication called Glyburide, which is typically used to manage blood sugar levels in people with diabetes. Researchers want to see if Glyburide can help protect the nervous system and improve recovery after an acute spinal cord injury, specifically in patients who have experienced trauma to their neck (cervical) or upper back (thoracic) regions. The trial is currently looking for participants aged 65 to 74 and 29 to 219 years old, as long as they do not have life-threatening injuries or signs of infection.

To be eligible for this study, participants must have a spinal cord injury that is serious but not the worst type (classified as Grade A, B, or C on a specific scale), and their injury must not be caused by a penetrating injury (like a gunshot). Participants should be able to undergo a neurological assessment within the first 8 hours after the injury. Those with certain health conditions, such as severe kidney or liver issues, or those who are currently involved in other research studies, will not be eligible. If you join the trial, you will be monitored closely to assess how well Glyburide works and to ensure your safety throughout the process.

Gender

ALL

Eligibility 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