Spinal Cord Injury Neuroprotection With Glyburide (SCING)

University of Kentucky

Status and phase

Enrolling

Phase 1

Conditions

Acute Spinal Cord Injury

Treatments

Drug: GlyBURIDE Oral Tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT05426681

77662

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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