Clinical trial NCT05426681: Spinal Cord Injury Neuroprotection With Glyburide
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Acute Spinal Cord Injury
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This study will include subjects between 18 and 80 years who have experienced acute traumatic cervical or thoracic spinal cord injury. Subjects will begin an oral drug regimen of Glyburide with the initial dose being within 8 hours of the injury and again every 6 hours after for 72 total hours of treatment. The daily dose of 3.125mg on day one and 2.5 mg on days 2 and 3 will be used to determine if the investigational drug provides any neuroprotection when given soon after injury. If indicated, the subject will also have surgical intervention for spinal cord decompression surgery and spinal stabilization. Participants will have labs drawn regularly, and ECGs done throughout their hospital stay. Adverse events will be monitored daily through day 14 of participation or hospital discharge (whichever is earlier). Study participation will last for 365 days (+/- 30 days), with post-hospitalization follow-up occurring on days 28, 42, 84, 182, and 365.

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

Primary outcomes:
measure: Rate of recruitment of patients with tSCI within the specified time window.
timeFrame: within 8 hours of tSCI
measure: Number of drug related adverse events.
timeFrame: One year post treatment
Secondary outcomes:
measure: Neurologic recovery following tSCI
timeFrame: One year post enrollment.
measure: Serum Pharmacokinetics to measure Glyburide concentrations.
timeFrame: Enrollment through post-treatment day 7.
measure: Biomarker Analysis
timeFrame: Enrollment, Day 3, and Day 7
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
References: