Intervention: Glyburide
Trial phase: Phase 1 | Phase 2
ATC code: A10BB01
SMILES: COc1ccc(Cl)cc1C(=O)NCCc1ccc(S(=O)(=O)NC(=O)NC2CCCCC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Enrolled patients will receive 12 doses of Glyburide starting within 8 hours of SCI. The dosing regimen involves an initial dose of 1.25 mg followed by eleven 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.

Glyburide: 3 day drug regimen beginning 8 hours after acute traumatic spinal cord injury.
Eligibility criteria:
Inclusion Criteria:

Age: ≥ 18 years and ≤ 80 years
Written informed consent by patient or legal authorized representative
No other life-threatening injury
No evidence of sepsis
Acute cervical SCI with ASIA Impairment Scale grade A, B or C on admission
Non-penetrating SCI at neurologic level from C2 to C8
Initiation of study drug within 8 hours of injury

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
Other illness (including mental disorder) that could preclude accurate medical and neurological evaluation (at discretion of the site investigator)
Unable to commit to the follow-up schedule
A recent history of regular substance abuse (illicit drugs, alcohol), which in the opinion of the investigator would interfere with the subject's participation in the study
Any condition likely to result in the patient's death within the next 12 months
Prisoner
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 > 2 times upper limit normal. Subjects may be randomized if liver function tests have been drawn but are not yet available and the subject has no known history of liver disease; however, treatment with DiaBeta will be discontinued prior to the second dose if liver function tests indicate ALT > 3 times upper limit of normal or bilirubin > 2 times upper limit of normal
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 treatment with Bosentan within past 7 days
Known G6PD enzyme deficiency
Pregnancy: Women must be either post-menopausal, permanently sterilized or, if ≤ 50 years old, must have a negative test for pregnancy obtained before enrollment
Breast-feeding women who do not agree to stop breast-feeding during and for 7 days following the end of oral glyburide administration
Subjects who in the opinion of the investigator are not suitable for inclusion in the study (reason to be documented).