Recruiting
Phase 1

Glyburide

Sponsor:

Francis Farhadi

Code:

NCT05426681

Conditions

Acute Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

GlyBURIDE Oral Tablet

Study Details

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.

Conditions

Acute Spinal Cord Injury

Study ID

NCT05426681

Start date

Jul 7, 2022

Status verified date

Feb, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Glyburide treatment arm

Interventions

GlyBURIDE Oral Tablet

Enrolled patients will receive 12 doses of Glyburide starting within 8 hours of spinal cord injury. The dosing regimen involves an initial dose of 1.25mg followed by 11 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.

Intervention: Drug: Glyburide

Primary outcome measure

  • Rate of recruitment of patients with tSCI within the specified time window. [ Time Frame: within 8 hours of tSCI ]
  • Number of drug related adverse events. [ Time Frame: One year post treatment ]

Central Contacts and Locations

Central contacts

H. Francis Farhadi, MD, PhD

859-323-5661francis.farhadi@uky.edu

Harshit Arora, PhD

859-323-4533harshit.arora@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Francis Farhadi, MD, PhD

859-562-0247francis.farhadi@uky.edu

Harshit Arora, PhD

859-323-4533harshit.arora@uky.edu

More Information

Sponsor

Francis Farhadi

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Francis Farhadi on 2026-02-13.