Using Glyburide to protect the spinal cord after injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using ultrasound to improve treatment for acute spinal cord injury

  This study is testing if using special ultrasound during spinal surgery can help doctors see blood flow in patients with acute spinal cord injuries to improve their treatment and recovery.

  Recruiting Phase 4 University of Washington · Seattle, Washington · NCT06654804

• Improving cough in individuals with acute spinal cord injury using electrical stimulation and muscle training

  This study tests if using electrical stimulation and muscle training can help people with recent spinal cord injuries improve their ability to cough on their own.

  Recruiting University of Miami · Miami, Florida · NCT05745298

• Transcutaneous spinal stimulation to improve blood pressure after a recent spinal cord injury

  We will try a noninvasive spinal stimulation to see if it raises and steadies blood pressure in people 7–30 days after a thoracic spinal cord injury who have low blood pressure or dizziness when sitting up.

  Recruiting Kessler Foundation · West Orange, New Jersey · NCT05731986

• Using Transcutaneous Spinal Cord Stimulation to stabilize blood pressure after spinal cord injury

  This study is testing whether a new method using Transcutaneous Spinal Cord Stimulation can help stabilize blood pressure in people with recent spinal cord injuries during their rehab.

  Recruiting Icahn School of Medicine at Mount Sinai · New York, New York · NCT05305118

• Evaluating blood biomarkers for spinal cord injury recovery

  This study is testing whether certain blood markers can help doctors understand the severity of spinal cord injuries and predict how well patients will recover.

  Recruiting University of British Columbia · Vancouver, British Columbia · NCT05244408

• Treatment for Acute Spinal Cord Injury using Sovateltide

  This study is testing a new drug called sovateltide to see if it can help people with acute spinal cord injuries recover better when given soon after their injury.

  Recruiting at 4 sites Phase 2 Pharmazz, Inc. · Belagavi and 4 other locations · NCT04054414

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.