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Sulfonylureas

Glyburide for Spinal Cord Injury (SCING Trial)

Phase 1
Recruiting
Research Sponsored by University of Kentucky
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No evidence of sepsis
Non-penetrating SCI at neurologic level from C2 to C8 or T1 to T12
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year post treatment
Awards & highlights
No Placebo-Only Group

Summary

This trialtests if a diabetes drug can help protect spinal cord injury patients from further damage.

Who is the study for?
This trial is for adults with recent non-penetrating spinal cord injuries at certain levels, who are not in immediate life-threatening condition and can undergo neurological assessment within 8 hours. Excluded are those with severe heart issues, other major health problems like liver or kidney disease, low blood glucose levels, or a known allergy to sulfonylureas.
What is being tested?
The study tests if Glyburide (Diabeta), an oral tablet commonly used for diabetes, can protect the nerves after acute traumatic injury to the cervical or thoracic spine. The goal is to see if it's safe and effective in improving outcomes for these patients.
What are the potential side effects?
While specific side effects of Glyburide in this context aren't listed here, common ones include low blood sugar (hypoglycemia), nausea, headache, dizziness and potential allergic reactions. Side effects may vary based on individual patient conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have sepsis.
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My spinal cord injury is between my neck and mid-back without piercing the cord.
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My spinal cord injury is severe but not complete, affecting my neck or upper back.
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I have no life-threatening injuries from an accident.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe kidney issues or am on dialysis.
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I do not have severe liver disease or significantly high liver enzyme levels.
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I was unable to undergo a neurological assessment due to unconsciousness or mental impairment within the first 8 hours.
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My spinal cord injury is mild, allowing me some movement.
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My blood sugar is below 55 mg/dL or I have a history of low blood sugar.
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I have a known G6PD enzyme deficiency.
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I have had recent serious heart issues or a heart attack in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year post enrollment.
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year post enrollment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of drug related adverse events.
Rate of recruitment of patients with tSCI within the specified time window.
Secondary study objectives
Biomarker Analysis
Neurologic recovery following tSCI
Serum Pharmacokinetics to measure Glyburide concentrations.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Glyburide treatment armExperimental Treatment1 Intervention

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of KentuckyLead Sponsor
192 Previous Clinical Trials
223,610 Total Patients Enrolled

Media Library

Glyburide (Sulfonylureas) Clinical Trial Eligibility Overview. Trial Name: NCT05426681 — Phase 1
Spinal Cord Injury Research Study Groups: Glyburide treatment arm
Spinal Cord Injury Clinical Trial 2023: Glyburide Highlights & Side Effects. Trial Name: NCT05426681 — Phase 1
Glyburide (Sulfonylureas) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05426681 — Phase 1
~6 spots leftby May 2027
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