NCT05426681 Spinal Cord Injury Neuroprotection With Glyburide
| NCT ID | NCT05426681 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Francis Farhadi |
| Condition | Acute Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2022-07-07 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2022-07-07 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Francis Farhadi, MD, PhD
PRINCIPAL INVESTIGATOR
University of Kentucky
Frequently Asked Questions
Who can join the NCT05426681 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Acute Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05426681 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05426681 currently recruiting?
Yes, NCT05426681 is actively recruiting participants. Contact the research team at francis.farhadi@uky.edu for enrollment information.
Where is the NCT05426681 trial being conducted?
This trial is being conducted at Lexington, United States.
Who is sponsoring the NCT05426681 clinical trial?
NCT05426681 is sponsored by Francis Farhadi. The principal investigator is Francis Farhadi, MD, PhD at University of Kentucky. The trial plans to enroll 12 participants.