Spinal Cord Injury Neuroprotection With Glyburide

NCT05426681 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 77662
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Rate of recruitment of patients with tSCI within the specified time window.

  A measure of feasibility of undertaking a large phase II study among this population of patients where treatment must begin within a short injury-to-drug time window.

  within 8 hours of tSCI

• Number of drug related adverse events.

  A measure of safety of treating patients with traumatic spinal cord injury with Glyburide administered orally.

  One year post treatment

Secondary Outcomes (3)

• Neurologic recovery following tSCI

  One year post enrollment.

• Serum Pharmacokinetics to measure Glyburide concentrations.

  Enrollment through post-treatment day 7.

• Biomarker Analysis

  Enrollment, Day 3, and Day 7

Study Arms (1)

Glyburide treatment arm

EXPERIMENTAL

Drug: GlyBURIDE Oral Tablet

Interventions

GlyBURIDE Oral Tablet DRUG

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

Also known as: Diabeta

Glyburide treatment arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Francis Farhadi: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

MeSH Terms

Interventions

Glyburide

Intervention Hierarchy (Ancestors)

Sulfonylurea Compounds; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Study Officials

• Francis Farhadi, MD, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

H. Francis Farhadi, MD, PhD

CONTACT

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

Harshit Arora, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Neurosurgery

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 22, 2022
• Study Start: July 7, 2022
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)