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Recruiting NCT05426681

Spinal Cord Injury Neuroprotection With Glyburide

Phase I Interventional Acute Spinal Cord Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GlyBURIDE Oral Tablet.
Who it may be relevant to
Registry conditions: Acute Spinal Cord Injury. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug GlyBURIDE Oral Tablet
    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

Primary outcome measures

  • Rate of recruitment of patients with tSCI within the specified time window. [Time frame: within 8 hours of tSCI]
  • Number of drug related adverse events. [Time frame: One year post treatment]
Secondary outcome measures (3)
  • Neurologic recovery following tSCI [Time frame: One year post enrollment.]
  • Serum Pharmacokinetics to measure Glyburide concentrations. [Time frame: Enrollment through post-treatment day 7.]
  • Biomarker Analysis [Time frame: Enrollment, Day 3, and Day 7]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Kentucky — Lexington

Identifiers

NCT: NCT05426681 · 77662

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗