Spinal Cord Injury Neuroprotection With Glyburide

Description

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.

Conditions

Acute Spinal Cord Injury

Study Overview

Study Details

Study 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.

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

Spinal Cord Injury Neuroprotection With Glyburide

Condition
Acute Spinal Cord Injury
Intervention / Treatment

-

Contacts and Locations

Lexington

University of Kentucky, Lexington, Kentucky, United States, 40536

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Kentucky,

Study Record Dates

2028-05