RECRUITING

Spinal Cord Injury Neuroprotection With Glyburide

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Conditions

Acute Spinal Cord Injury

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2022-07-07
Study Completion:2028-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05426681

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * No life threatening injuries resulting from the traumatic accident
  2. * No evidence of sepsis
  3. * Acute cervical or thoracic SCI with ASIA Impairment Scale Grade A, B, or C od admission.
  4. * Non-penetrating SCI at neurologic level from C2 to C8 or T1 to T12
  1. * Unconsciousness or other mental impairment that prevents neurological assessment within the first 8 hours
  2. * Acute SCI with ASIA Impairment Scale grade D or E
  3. * Currently involved in another non-observational SCI research study or receiving another investigational drug
  4. * History of hypersensitivity to sulfonylureas, in particular glyburide, or any of its components
  5. * Any condition likely to result in the patient's death within the next 12 months
  6. * Severe renal disorder from the patient's history (e.g. dialysis) or baseline eGFR of \< 30 mL/min/1.73 m2
  7. * Known severe liver disease, or ALT \> 3 times upper limit of normal or bilirubin
  8. * Blood glucose \<55 mg/dL at enrollment or immediately prior to administration of DiaBeta, or a clinically significant history of hypoglycemia
  9. * 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
  10. * Known G6PD enzyme deficiency

Contacts and Locations

Study Contact

H. Francis Farhadi, MD, PhD
CONTACT
859-323-5661
francis.farhadi@uky.edu
Jaimie L Hixson, BS
CONTACT
8593231908
jlhend3@uky.edu

Study Locations (Sites)

University of Kentucky
Lexington, Kentucky, 40536
United States

Collaborators and Investigators

Sponsor: University of Kentucky

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-07
Study Completion Date2028-05

Study Record Updates

Study Start Date2022-07-07
Study Completion Date2028-05

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Spinal Cord Injury