Using Glyburide to protect the spinal cord after injury
Spinal Cord Injury Neuroprotection With Glyburide (SCING): Pilot Study: An Open-Label Prospective Evaluation of the Feasibility, Safety, Pharmacokinetics, and Preliminary Efficacy of Oral Glyburide (DiaBeta) in Patients With Acute Traumatic Spinal Cord Injury
This study is testing if giving the medication Glyburide soon after a spinal cord injury can help improve recovery for adults aged 18 to 80.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT05426681 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of Glyburide, an oral medication, as a neuroprotective treatment for patients who have suffered acute cervical or thoracic spinal cord injuries. Participants aged 18 to 80 will receive Glyburide starting within 8 hours of their injury, followed by doses every 6 hours for 72 hours. The study will monitor participants for adverse events and assess their neurological status over a year, including follow-up visits at specified intervals. The goal is to determine if early administration of Glyburide can improve outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who have sustained acute non-penetrating cervical or thoracic spinal cord injuries.
Not a fit: Patients with severe renal or liver disease, or those with grade D or E spinal cord injuries, are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery and quality of life for patients with acute spinal cord injuries.
How similar studies have performed: While the use of Glyburide for neuroprotection is a novel approach, similar studies have shown promise in other contexts, but this specific application is less tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lexington, Kentucky
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Francis Farhadi, MD, PhD — University of Kentucky
- Study coordinator: H. Francis Farhadi, MD, PhD
- Email: francis.farhadi@uky.edu
- Phone: 859-323-5661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.